Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXParticipants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; participants with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and participants with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXPeople with autoimmune diseaseXx_NEWLINE_xXPatients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enrollXx_NEWLINE_xXNo patients with an active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barre; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXNo patients with known active autoimmune disease or known history of autoimmune disease for which recurrence may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis; patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including type I diabetes mellitus or thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligibleXx_NEWLINE_xXNo active known or suspected autoimmune disease; the following are permitted: patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune or non-autoimmune condition requiring hormone replacement, asymptomatic hypothyroidism not requiring treatment, psoriasis not requiring systemic treatment, or conditions not expected to recurXx_NEWLINE_xXPatients must not have any known autoimmune diseaseXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-4) therapy that has been completely resolved for more than 4 weeks prior to C1D1.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXHas an active or inactive autoimmune processXx_NEWLINE_xXPatients with active, known or suspected autoimmune disease except for autoimmune thyroiditis or vitiligo. Thyroiditis patients must be asymptomatic, on adequate thyroid replacement and have normal thyroid function tests.Xx_NEWLINE_xXAny prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and by laboratory testing)Xx_NEWLINE_xXPresence of active autoimmune disease, symptoms, or conditions, with the following exceptions:\r\n* Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, asymptomatic laboratory evidence of autoimmune disease (e.g.: positive anti-nuclear antibody [+ANA], positive rheumatoid factor [+RF], antithyroglobulin antibodies), or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease requiring disease-modifying therapy at the time of Screening.Xx_NEWLINE_xXParticipants with active, known, or suspected autoimmune diseaseXx_NEWLINE_xXActive or prior autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.Xx_NEWLINE_xXParticipants with active autoimmune disease; participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency;Xx_NEWLINE_xXHistory of autoimmune disease or of confirmed progressive multifocal leukoencephalopathyXx_NEWLINE_xXHistory of active autoimmune disordersXx_NEWLINE_xXSubjects with active, known, or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXPatients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with Medical Monitor approval).Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXAn active, known or suspected autoimmune disease; the following are exceptions:\r\n* Vitiligo\r\n* Hemolytic anemia associated with the lymphoma (history of or at the present time)\r\n* Type I diabetes mellitus\r\n* Residual hypothyroidism due to autoimmune condition only requiring hormone replacement\r\n* Psoriasis not requiring systemic treatment, or \r\n* Conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXThe subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXParticipant must not have an active or prior documented autoimmune disease in the last 2 years.Xx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive known or suspected exclusionary autoimmune diseaseXx_NEWLINE_xXPatients with active, known or suspected autoimmune disease.Xx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXSubjects with an active, known, or suspected autoimmune diseaseXx_NEWLINE_xXSubject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitisXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopenia.Xx_NEWLINE_xXPatients with active autoimmune diseases or history of autoimmune diseases should be excluded; these include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematous (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's ulcerative colitis, hepatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Note: Patient are permitted to enroll if they have controlled celiac disease, vitiligo, eczema, psoriasis, controlled Type I diabetes mellitus, endocrine deficiencies (including hypothyroidism) managed with replacement hormones including low-dose (?10 mg/day prednisone equivalents) corticosteroids. Patients with rheumatological autoimmune diseases that are frequently limited in severity such as rheumatoid arthritis and Sjogren's syndrome are permitted to enroll if they do not require treatment with a non-biologic or biologic disease modifying anti-rheumatic drug (DMARDs), e.g. cyclophosphamide or adalimumab. All patients with an autoimmune rheumatological disease require evaluation for severity and target organ involvement.Xx_NEWLINE_xXHistory of or active autoimmune disordersXx_NEWLINE_xXActive, suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegner's granulomatosis and Hashimoto's thyroiditis). Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXSubjects with active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enrolXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other systemic autoimmune disease.Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of symptomatic autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease, or documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXActive autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment; hypothyroidism without evidence of Grave’s disease or Hashimoto’s thyroiditis is permittedXx_NEWLINE_xXActive autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditisXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXActive known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).Xx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXParticipants with an active, known, or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXAny active or inactive autoimmune disease or syndromeXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPHASE II EXCLUSION CRITERIA: Subjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXSubjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) or who are receiving systemic therapy for an autoimmune disease; exceptions include vitiligo, hypothyroidism controlled on hormone replacement, type I diabetes, Grave’s disease,\r\nadrenal insufficiency on stable replacement doses of steroids (prednisone =< 10 mg/day or equivalent), or with principal investigator approvalXx_NEWLINE_xXPatients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.Xx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXPatients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agent.Xx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)Xx_NEWLINE_xXActive, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseasesXx_NEWLINE_xXAn active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or a history of severe autoimmune disease or syndromeXx_NEWLINE_xXParticipants must not have an active, known or suspected autoimmune disease; participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of, active or suspicion of autoimmune diseaseXx_NEWLINE_xXPatient has active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXHistory or risk of autoimmune diseaseXx_NEWLINE_xXThe participant has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXEXCLUSION - INFUSION: Uncontrolled autoimmune disease needing systemic steroids or steroid sparing agents except for hypothyroidism or type I diabetesXx_NEWLINE_xXActive or history of any autoimmune disease (subjects with diabetes type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible).Xx_NEWLINE_xXActive, known or suspected autoimmune disease. Patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.Xx_NEWLINE_xXAny active history of a known autoimmune disease; subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive, suspected or prior documented autoimmune disease that has required systemic treatment in the last 2 years with immune modifying agents (e.g. replacement therapy such as thyroxine, insulin or physiologic corticosteroids is not an exclusion criteria); this does not include patients with vitiligo or type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease.Xx_NEWLINE_xXHistory of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)Xx_NEWLINE_xXClinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severityXx_NEWLINE_xXActive or known autoimmune diseaseXx_NEWLINE_xXAny diagnosis of autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, adrenal insufficiency on replacement dose steroids, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPrimary or secondary immunodeficiency (including immunosuppressive disease, autoimmune disease [including autoimmune endocrinopathies, such as hypothyroidism, and insulin dependent diabetes mellitus], or usage of immunosuppressive medications).Xx_NEWLINE_xXPatients with chronic autoimmune disease(s) requiring systemic immunosuppression.Xx_NEWLINE_xXActive, known or suspected autoimmune disease.Xx_NEWLINE_xXPatients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligibleXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXAny isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)Xx_NEWLINE_xXHistory of, or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren´s syndrome, scleroderma, myasthenia gravis, Goodpasture´s syndrome, Addison´s disease, Hashimoto’s thyroiditis, or Grave's disease) as determined by the treating medical oncologist\r\n* Persons with vitiligo are not excluded\r\n* Persons with a history of type 1 diabetes are not excluded if the condition is well controlled:\r\n** Hemoglobin A1C < 7.0, and\r\n** No evidence of end-organ damage due to diabetes, such as diabetic retinopathy, nephropathy, or neuropathy\r\n** Persons with type 2 diabetes are not excluded since this is not an autoimmune disease, and do not need to meet these criteria\r\n* Persons with hypothyroidism are not excluded if condition is well controlled, and condition is due to a non-autoimmune etiologyXx_NEWLINE_xXHistory of autoimmune disease including rheumatoid arthritis, systemic lupus and sarcoidosisXx_NEWLINE_xXPatients with an active, known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune hemolytic anemia or autoimmune thrombocytopenia.Xx_NEWLINE_xXStudy subjects with known autoimmune disease (e.g. systemic lupus erythematosus [SLE], rheumatoid arthritis [RA]) who have had significant symptoms within the past 3 years. Study subjects with vitiligo are not excludedXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of severe autoimmune disorders requiring use of steroids or other immunosuppressivesXx_NEWLINE_xXParticipants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:\r\n* The presence of laboratory evidence of autoimmune disease (e.g. positive antinuclear antibodies [ANA] titer) without symptoms.\r\n* Clinical evidence of vitiligo.\r\n* Hypothyroidism of any etiology on stable thyroid hormone replacement therapy.\r\n* Other forms of depigmenting illness.\r\n* Mild arthritis requiring nonsteroidal antiinflammatory drug (NSAID) medications.Xx_NEWLINE_xXPatients with any active autoimmune diseaseXx_NEWLINE_xXPatients with autoimmune diseaseXx_NEWLINE_xXClinically active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE]) requiring treatment; vitiligo, diabetes, or treated thyroiditis are allowedXx_NEWLINE_xXPresence of autoimmune disease that requires corticosteroids and/or immunosuppressive agents.Xx_NEWLINE_xXSystemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma)Xx_NEWLINE_xXHistory of major organ autoimmune diseaseXx_NEWLINE_xXActive, known or suspected autoimmune disease.\r\n* Subjects with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXPatients with a history of autoimmune hypothyroidism (such as atrophic thyroiditis) on a stable dose of thyroid replacement hormone may be eligible.Xx_NEWLINE_xXPatients with active, known, or suspected autoimmune disease; patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll; for any cases of uncertainty, it is recommended that the principal investigator be consulted prior to signing informed consentXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXActive, known, or suspected autoimmune disease with the following exceptions\r\n* Subjects with vitiligo, type I diabetes mellitus, resolved childhood asthma or atopy are permitted to enroll\r\n* Subjects with suspected autoimmune thyroid disorders may be enrolled if they are currently euthyroid or with residual hypothyroidism requiring only hormone replacement\r\n* Subjects with psoriasis requiring systemic therapy must be excluded from enrollmentXx_NEWLINE_xXSubject has active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment.Xx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency;Xx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive therapyXx_NEWLINE_xXSubjects with an active or known autoimmune disease; subjects with type I diabetes mellitus, hypo- or hyperthyroidism only requiring hormone replacement/suppression, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic immunosuppressive treatment are eligibleXx_NEWLINE_xXAn active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.Xx_NEWLINE_xXSubjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; autoimmune-related thyroid disease, type I diabetes and vitiligo are permitted if the condition is well controlledXx_NEWLINE_xXPatient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .Xx_NEWLINE_xXParticipants must not have an active, known, or suspected autoimmune diseaseXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring chronic and systemic immunosuppressive treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects have any other condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days. Inhaled or topical steroids and adrenal replacement doses > 10mg daily prednisone equivalent are permitted in absence of active autoimmune disease.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive autoimmune condition requiring systemic immunosuppressive medicationXx_NEWLINE_xXDeveloped autoimmune disorders of Grade 4 while on prior immunotherapy. Subjects who developed autoimmune disorders, of Grade ? 3 may enroll if the disorder has resolved to Grade ?1 and the subject has been off systemic steroids at doses >10 mg/day, for the treatment of the autoimmune disorder, for at least 2 weeks.Xx_NEWLINE_xXHistory of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.Xx_NEWLINE_xXSubjects with active, known, or suspected autoimmune disease including patients with a history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease); patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), and central nervous system or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis). Subjects with vitiligo, type I diabetes mellitus, Grave’s disease, Hashimoto thyroiditis, psoriasis, and other mild autoimmune disease not requiring systemic treatment are permitted to enroll at the discretion of the investigator.Xx_NEWLINE_xXPatients cannot have active autoimmune disease or immunosuppressive conditionsXx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disordersXx_NEWLINE_xXAutoimmune disease requiring treatment within the last 5 years including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, uveitis, or other if clinically significantXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immune-stimulatory agent per treating physician’s clinical judgment. Subjects with type 1 diabetes, vitiligo, psoriasis, hypothyroidism, or hyperthyroidism not requiring immunosuppressive medications are eligibleXx_NEWLINE_xXAny diagnosis of autoimmune disease (confirmed by medical records or appropriate laboratory testing)Xx_NEWLINE_xXPatients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantationXx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.Xx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excludedXx_NEWLINE_xXPatients with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant)Xx_NEWLINE_xXUncontrolled autoimmune disease requiring active systemic treatmentXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXPatients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.Xx_NEWLINE_xXPatients with active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible.Xx_NEWLINE_xXActive autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entryXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disease with some exceptionsXx_NEWLINE_xXHistory of or current active autoimmune diseasesXx_NEWLINE_xXPatients/subjects with autoimmune diseaseXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXPatients with active or a known history of known or suspected autoimmune disease are ineligible; subjects with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enrollXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidismXx_NEWLINE_xXParticipants with chronic autoimmune diseasesXx_NEWLINE_xXAutoimmune disease or history of primary immunodeficiency (excluding Hashimoto’s thyroiditis, vitiligo, or DM type I)Xx_NEWLINE_xXSubjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; the following conditions are not exclusions (subjects with the following conditions are permitted):\r\n* Patients with diabetes type I, vitiligo, residual hypo- or hyperthyroidism due to autoimmune condition only requiring hormone replacement, or psoriasis not requiring systemic immunosuppressive treatment, or autoimmune conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXDocumented history of clinically significant autoimmune disease (other than well-controlled hypothyroidism) or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive therapyXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXSubjects with active autoimmune disease or a syndrome that requires systemic corticosteroidsXx_NEWLINE_xXAn active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXActive autoimmune disease or a history of severe autoimmune disease or syndromeXx_NEWLINE_xXNo history of or current diagnosis of a 'significant autoimmune disease” or paraneoplastic autoimmune disease, i.e. myasthenia gravis, Lambert-Eaton, systemic lupus, rheumatoid arthritis. For minor 'autoimmune' disorders such as psoriasis, arthritis (not including rheumatoid arthritis), Reynauld’s disease; these are allowed onto trial.Xx_NEWLINE_xXAutoimmune disorders (e.g., Crohn’s disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system except patients who have grade 1 psoriasis (in remission or controlled with topical steroids) or mild degree of autoimmune thyroiditis that are controlled with medicationsXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXActive autoimmune disease requiring ongoing systemic immunosuppressive therapyXx_NEWLINE_xXKnown or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study. Patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive, known, or suspected autoimmune disease or any autoimmune condition that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed); subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXMedical contraindication to radiation treatment (e.g. active systemic sclerosis, other uncontrolled autoimmune condition)Xx_NEWLINE_xXCurrent autoimmune disease or history of autoimmune disease with potential CNS involvement.Xx_NEWLINE_xXHistory of major organ autoimmune disease.Xx_NEWLINE_xXSubjects with active, known or suspected systemic autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXActive, known, or suspected autoimmune diseaseXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders are NOT permitted; the following are EXCEPTIONS to this criterion and are allowed\r\n* Patients with vitiligo or alopecia, type I diabetes mellitus\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome)\r\n* Any chronic autoimmune or inflammatory skin condition that does not require systemic therapy\r\n* Patients without active disease requiring treatment in the last 3 years may be included but only after consultation with principal investigator\r\n* Patients with celiac disease controlled by diet alone may be included but only after consultation with principal investigatorXx_NEWLINE_xXPatients with history of or active autoimmune disease including thyroiditis, colitis, nephritis, neuropathy or pneumonitisXx_NEWLINE_xXHistory of severe autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.Xx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXParticipants with chronic autoimmune diseaseXx_NEWLINE_xXHas a diagnosis of active scleroderma or lupus or any other autoimmune disease that by the opinion of the treating radiation oncologist would put the patient at unacceptable risk of toxicityXx_NEWLINE_xXAutoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus; Note: vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowedXx_NEWLINE_xXActive and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >= 20 mg.Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent per treating physician’s clinical judgment; subjects with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXPatients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopeniaXx_NEWLINE_xXclinical history, prior diagnosis, or overt evidence of autoimmune diseaseXx_NEWLINE_xXAutoimmune disease (Note: Vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, and conditions not expected to recur in the absence of an external trigger are permitted.)Xx_NEWLINE_xXHistory of or known or suspected autoimmune disease (exception[s]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed).Xx_NEWLINE_xXPatients with active, known, or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disordersXx_NEWLINE_xXActive or history of medically significant autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXNo active autoimmune disease or a history of known or suspected autoimmune disease except as detailed in the exclusion criteria belowXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy > 20 mg prednisone daily or equivalent, within 7 days of starting venetoclaxXx_NEWLINE_xXFOR ALL PHASES (Ib AND II): History of, or current autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapy.Xx_NEWLINE_xXAny active known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition or prior therapy requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with chronic autoimmune diseaseXx_NEWLINE_xXActive, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur.Xx_NEWLINE_xXHistory of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusionXx_NEWLINE_xXPatients who have active, known, or suspected autoimmune disease are not eligible. However, patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition that requires only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients are excluded if they have an active, known or suspected autoimmune disease other than those listed below; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXCRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: Active autoimmune disease requiring immunosuppressive therapy, unless considered by the PI or designee to be eligibleXx_NEWLINE_xXPatients on long term systemic steroids (>10 mg daily prednisone equivalent). Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll at the discretion of the principle investigator. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.Xx_NEWLINE_xXAutoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapyXx_NEWLINE_xXPatients with active known autoimmune disease are ineligibleXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agent; patients with diabetes type 1, vitiligo, psoriasis, pure red cell aplasia, Good’s syndrome or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive, known or suspected autoimmune disease\r\n* Note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatmentXx_NEWLINE_xXSubjects with active, known, or suspected autoimmune disease; subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll; for any cases of uncertainty, it is recommended that the medical monitor be consulted prior to signing informed consentXx_NEWLINE_xXPatients who are on treatment for rheumatological or autoimmune disease unless approved by the Investigator in consultation with the Sponsor (e.g., as for replacement therapy for autoimmune thyroiditis or diabetes).Xx_NEWLINE_xXAny active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger; subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll; patients with psoriasis not requiring active, systemic treatment are allowedXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n** NOTE: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive uncontrolled autoimmune cytopeniasXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXActive, known or suspected autoimmune disease; Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive therapyXx_NEWLINE_xXHistory of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.Xx_NEWLINE_xXActive or chronic autoimmune diseasesXx_NEWLINE_xXHistory of autoimmune disease except for controlled, treated thyroidism or Type 1 diabetesXx_NEWLINE_xXAny active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; subjects with vitiligo, controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy are permitted to enrollXx_NEWLINE_xXPatients/subjects with autoimmune diseaseXx_NEWLINE_xXActive, known, or suspected autoimmune disease or infectionXx_NEWLINE_xXPatients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorderXx_NEWLINE_xXOngoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse eventsXx_NEWLINE_xXHistory of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.Xx_NEWLINE_xXSubjects with active, known, or suspected autoimmune disease are excludedXx_NEWLINE_xXActive autoimmune diseases requiring systemic treatmentsXx_NEWLINE_xXKnown or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study; patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participateXx_NEWLINE_xXActive autoimmune disease with reasonable possibility of clinically significant deterioration when receiving an immuno-stimulatory agent; subjects with type 1 diabetes mellitus, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive autoimmune disease; patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, psoriasis not requiring systemic treatment, or vitiligo are permitted for enrollmentXx_NEWLINE_xXAutoimmune diseases such as rheumatoid arthritis are NOT allowed; vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowedXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXActive autoimmune disease or a history of known or suspected autoimmune disease with the exception of subjects with isolated vitiligo, treated thyroiditis or resolved childhood asthma/atopyXx_NEWLINE_xXHistory of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; use of immunosuppressant drugs such as systemic steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc.: systemic use is not permitted within 4 weeks before recruitmentXx_NEWLINE_xXPatients with a recent history (within last 5 years) of autoimmune disease or inflammatory diseases will be excluded; exceptions will be allowed for vitiligo and hypothyroidism that has been stable on thyroid replacement medications for > 6 weeksXx_NEWLINE_xXHistory of autoimmune disorder with exception of eligible patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation; use of immunosuppressant drugs such as steroids (except as hormone replacement therapy), azathioprine, tacrolimus, cyclosporine, etc. is not permitted within\r\n4 weeks before recruitmentXx_NEWLINE_xXHas an active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism, interstitial lung disease, colitisXx_NEWLINE_xXPatients with significant autoimmune disease that is active or potentially life threatening if activatedXx_NEWLINE_xXAutoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significantXx_NEWLINE_xXActive, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism and/or hypophysitis due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn's\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* Leptomeningeal disease\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive or prior documented autoimmune disease within the past 3 years\r\n* NOTE: subjects with active, known or suspected autoimmune disease such as vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXCurrent autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences/manifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson’s disease, cerebellar disease, or psychosisXx_NEWLINE_xXAutoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, that is active and requires current immunosuppressive therapyXx_NEWLINE_xXAny active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXPatients with autoimmune diseases such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis or pancreatitis, and systemic lupus erythematosus; hypothyroidism, vitiligo and other minor autoimmune disorders are not exclusionaryXx_NEWLINE_xXActive, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapyXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.Xx_NEWLINE_xXHistory of major organ autoimmune diseaseXx_NEWLINE_xXHistory of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusionXx_NEWLINE_xXSubjects with any active, known, or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXKnown or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study; patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate; any condition requiring systemic treatment with corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug; inhaled steroids and adrenal replacement steroids doses > 10mg daily prednisone equivalents are permitted in the absence of active autoimmune diseaseXx_NEWLINE_xXAny active known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXThose with active autoimmune disease are excluded from the studyXx_NEWLINE_xXActive, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or equivalentXx_NEWLINE_xXThe subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of:\r\n* VitiligoXx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive therapyXx_NEWLINE_xXEXCLUSION CRITERIA FOR TNBC: Active autoimmune disease requiring immunosuppressive therapyXx_NEWLINE_xXActive autoimmune disease requiring disease-modifying therapyXx_NEWLINE_xXActive autoimmune disease.Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic progressive sclerosis [scleroderma and variants], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis] or autoimmune neuropathies (such as Guillain-Barre syndrome) are excluded from this study; vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionaryXx_NEWLINE_xXHistory of severe autoimmune disease requiring steroids or other immunosuppressive treatmentsXx_NEWLINE_xXDONOR: Concurrent malignancy or autoimmune diseaseXx_NEWLINE_xXActive, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapyXx_NEWLINE_xXHistory of major organ autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.Xx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease (e.g. inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, lupus, celiac disease); subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXHistory of autoimmune disease(s)Xx_NEWLINE_xXAny active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressants (excluding vitiligo, type 1 diabetes mellitus, Graves or Hashimoto’s disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, resolved childhood asthma/atopy and patients with asthma requiring intermittent bronchodilator therapy)\r\n* Examples include, but are not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system [CNS] or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis).Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune or immunosuppressive disease.Xx_NEWLINE_xXActive autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)Xx_NEWLINE_xXPatients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])Xx_NEWLINE_xXPatients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])Xx_NEWLINE_xXOngoing or recent significant autoimmune diseaseXx_NEWLINE_xXPatients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapyXx_NEWLINE_xXPatients with active, known, or suspected autoimmune disease\r\n* Participants with well-controlled asthma and/or mild allergic rhinitis (seasonal allergies) are eligible\r\n* Participants with the following disease conditions are also eligible: \r\n** Vitiligo,\r\n** Type 1 diabetes mellitus\r\n** Residual hypothyroidism due to autoimmune condition only requiring hormone replacement\r\n** Euthyroid participants with a history of Grave’s disease (participants suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug)\r\n** For patients with ITP (idiopathic thrombocytopenic purpura) or AIHA (autoimmune hemolytic anemia), a case by case discussion with study principal investigator (PI) may be consideredXx_NEWLINE_xXAutoimmune diseaseXx_NEWLINE_xXHistory of active autoimmune diseaseXx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXMust not have active autoimmune disease (see protocol for exceptions)Xx_NEWLINE_xXPatients with a history of life-threatening autoimmune diseaseXx_NEWLINE_xXHistory of chronic inflammatory or autoimmune diseaseXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive autoimmune disease requiring systemic therapy. Patients with a history of autoimmune disease must be counselled regarding the unknown potential of exacerbating or reactivating previous or dormant autoimmunity during the consent process.Xx_NEWLINE_xXKnown autoimmune diseaseXx_NEWLINE_xXHistory of prior or current autoimmune diseaseXx_NEWLINE_xXActive, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapyXx_NEWLINE_xXAutoimmune disorders on current immunosuppressive therapyXx_NEWLINE_xXNo active autoimmune disease or a history of known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; however, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolledXx_NEWLINE_xXKnown history of HIV or autoimmune diseases requiring immunosuppressant drugsXx_NEWLINE_xXPatients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvementXx_NEWLINE_xXAny prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvementXx_NEWLINE_xXPatients with any known or suspected, current or past history of, autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseases (such as systemic lupus erythematosus [SLE], Wegener's, Wegener's granulomatosis, polyarteritis nodosa); Note: Prior autoimmune diseases are allowed as long as clinically stableXx_NEWLINE_xXHistory of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditisXx_NEWLINE_xXSubjects are excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXMild autoimmune conditions (such as localized psoriasis) requiring minimal treatment or systemic autoimmune conditions well controlled by target agents such as an anti-IL-17 that do not affect overall immune systemXx_NEWLINE_xXKnown or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]) are excluded from this study; any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug; inhaled steroids and adrenal replacement steroids doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXPatients with active autoimmune disease or history of transplantation; patients with indolent or chronic autoimmune disease not requiring steroid treatment are considered eligibleXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXEvidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.Xx_NEWLINE_xXPre-existing autoimmune or antibody -mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis; patients with controlled thyroid disease, or the presence of auto-antibodies without clinical autoimmune disease, are permitted on studyXx_NEWLINE_xXPatients who exhibit any active or on-going autoimmune processes including, but not limited to, autoimmune hemolytic anemia or immune thrombocytopenia purpura, are NOT eligible for participationXx_NEWLINE_xXActive life-threatening autoimmune diseaseXx_NEWLINE_xXPatients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed\r\n* Replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to initiation of study treatment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study\r\n* Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligibleXx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of steroid medication for at least 2 weeks prior to initiation of therapy are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligibleXx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI)Xx_NEWLINE_xXImmuosuppressive disorders (chronic steroid therapy, acquired or congenital immune deficiency syndromes, autoimmune disease)Xx_NEWLINE_xXPatients with known active autoimmune disorderXx_NEWLINE_xXDONOR: History of autoimmune diseaseXx_NEWLINE_xXNo current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatmentXx_NEWLINE_xXHas active, known, or suspected autoimmune diseaseXx_NEWLINE_xXParticipants with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive or inactive autoimmune process.Xx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:Xx_NEWLINE_xXActive autoimmune or auto-inflammatory ocular disease within 6 monthsXx_NEWLINE_xXKnown or suspected active organ-threatening autoimmune diseaseXx_NEWLINE_xXPatients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome; at the discretion of the treating physician patients who show disease control for at least 6 months may be enrolledXx_NEWLINE_xXPatients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvementXx_NEWLINE_xXPatients with an active autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease as detailed aboveXx_NEWLINE_xXPatients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXSystemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).Xx_NEWLINE_xXAn active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.Xx_NEWLINE_xXPatients with active or documented history of autoimmune disease;Xx_NEWLINE_xXHas active autoimmune disease or history of autoimmune diseases at high risk for relapseXx_NEWLINE_xXPresence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapseXx_NEWLINE_xXActive autoimmune disease or documented history of autoimmune disease.Xx_NEWLINE_xXAny active autoimmune diseaseXx_NEWLINE_xXActive or history of any autoimmune disease (except type I diabetes mellitus [DM], vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment, which are allowed) or immunodeficienciesXx_NEWLINE_xXKnown autoimmune disease requiring active treatment.Xx_NEWLINE_xXActive/prior autoimmune of inflammatory disordersXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease.Xx_NEWLINE_xXPatients with active autoimmune anemia or autoimmune thrombocytopenia are NOT eligibleXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXActive or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent. However, patients with diabetes type 1, vitiligo, psoriasis, or hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are eligible;Xx_NEWLINE_xXActive or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXMust not have been diagnosed with autoimmune disease or be immunosuppressedXx_NEWLINE_xXActive autoimmune disease prior to transplantXx_NEWLINE_xXHave history of uncontrolled autoimmune disease.Xx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXActive autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes but is not limited to: history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. Patients with vitiligo or endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, and psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger (precipitating event) are eligibleXx_NEWLINE_xXActive autoimmune disease requiring immunosuppressive treatment or history of autoimmune disease requiring immunosuppressive therapy (e.g. requirement for systemic therapy with >10 mg/day prednisone-equivalent) or any other concurrent use of immunosuppressive therapy.Xx_NEWLINE_xXPatients with known active autoimmune disorderXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXParticipants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave’s disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussing with the principal investigatorXx_NEWLINE_xXNo history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)Xx_NEWLINE_xXHistory of major organ autoimmune diseaseXx_NEWLINE_xXSignificant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy.Xx_NEWLINE_xXHistory of active or prior documented autoimmune disease within the past 2 years including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, auto-immune Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following caveats:\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with Grave’s disease, vitiligo, autoimmune alopecia, or psoriasis not requiring systemic treatment (within the past 2 years) are eligible upon consultation with the study chairs\r\n* Patients with questionable diagnosis of autoimmune disease who have never been treated with immunosuppressive regimen and have no ongoing symptoms at the time of enrollment may be eligible after discussion with medical monitor and principle investigatorXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXKnown current or prior autoimmune disease with the exception of vitiligoXx_NEWLINE_xXAny active known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive, known, or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in absence of an external trigger.Xx_NEWLINE_xXAutoimmune disorders on current immunosuppressive therapyXx_NEWLINE_xXImmunosuppressed patients (cancer, autoimmune disease) or patients taking immunosuppressive drugsXx_NEWLINE_xXHas active autoimmune disease or history of transplantationXx_NEWLINE_xXHas autoimmune hepatitisXx_NEWLINE_xXAny active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXPatients with active autoimmune disease, with exceptions of vitiligo, type I diabetes mellitus, hypothyroidism and psoriasis.Xx_NEWLINE_xXActive, known or suspected autoimmune disease; note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXPatients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXExclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis); other CNS autoimmune disease (e.g., multiple sclerosis)Xx_NEWLINE_xXPatients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligibleXx_NEWLINE_xXThe subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: vitiligo, diabetes or thyroid dysfunctionXx_NEWLINE_xXActive, known, or suspected autoimmune disease; patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded; patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXSubjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications EXCEPT for syndromes which would not be expected to recur in the absence of an external trigger. (Subjects with vitiligo, autoimmune thyroiditis, or type I diabetes mellitus are permitted to enroll.)Xx_NEWLINE_xXHistory of, or current autoimmune diseaseXx_NEWLINE_xXPatients with autoimmune disease requiring systemic corticosteroid treatment (and previously ineligible to receive systemic immunotherapies for melanoma) are allowed on condition that they do not receive more than 20 mg of daily dose methylprednisolone, prednisone, or its equivalent; this does not include autoimmune diseases caused by previous immunotherapy treatments for melanoma that require ongoing treatment with corticosteroids (e.g. autoimmune colitis or autoimmune hepatitis receiving corticosteroids)Xx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXPatients with a history of autoimmune disease requiring continuous treatmentXx_NEWLINE_xXActive, known, or suspected autoimmune disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatmentXx_NEWLINE_xXSubjects with a history of known autoimmune disease are excluded from this studyXx_NEWLINE_xXParticipants that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting\r\n* The following will not be exclusionary:\r\n** The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer) without symptoms\r\n** Clinical evidence of vitiligo\r\n** Other forms of depigmenting illness\r\n** Mild arthritis requiring nonsteroidal antiinflammatory drug (NSAID) medicationsXx_NEWLINE_xXAutoimmune diseaseXx_NEWLINE_xXCurrent or history of systemic autoimmune disease requiring systemic therapy\r\n* NOTE: The following will not be exclusionary: \r\n** The presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without associated symptoms \r\n** Clinical evidence of vitiligo \r\n** Other forms of depigmenting illnessXx_NEWLINE_xXActive (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)Xx_NEWLINE_xXPatients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study \r\n* Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis)\r\n* Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligibleXx_NEWLINE_xXAny autoimmune disease such as inflammatory bowel disease, including but not limited to:\r\n* Ulcerative colitis\r\n* Crohn's disease\r\n* Rheumatoid arthritis\r\n* Systemic sclerosis\r\n* Systemic lupus erythematosus\r\n* Autoimmune hepatitis\r\n* Other autoimmune disease not listed above\r\n* NOTE: Subjects with autoimmune thyroid disease and diabetes mellitus type I will be allowedXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies (other than HTLV-associated arthropathy), and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXPatients with a history of autoimmune disease will also be excluded, specifically those with any active autoimmune disease or a condition that requires systemic corticosteroids; exceptions to this are subjects with vitiligo and type I diabetes mellitus, who will be permitted to enrollXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IRB), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\r\n* NOTE: patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXPatients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritisXx_NEWLINE_xXAutoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapyXx_NEWLINE_xXHistory of autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; active or inactive auto-immune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, etc.) requiring treatment\r\n* The following will not be exclusionary:\r\n** Vitiligo, thyroiditis or eczema requiring systemic steroids at a dose =< 7.5 mg/day of prednisone or equivalent; individual cases can be discussed with the principal investigatorXx_NEWLINE_xXPatients should have no evidence of being immunocompromised as listed below:\r\n* Human immunodeficiency virus positivity\r\n* Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; patients with endocrine disease that is controlled by replacement therapy including thyroid disease and adrenal disease and vitiligo may be enrolled\r\n* History of splenectomyXx_NEWLINE_xXParticipants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; participants must not have an active or inactive autoimmune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.); participants who are receiving therapy for an autoimmune or inflammatory disease requiring these therapies are also excludedXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\r\n* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXActive autoimmune diseases requiring treatment or a recent history of autoimmune disease requiring therapy, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis; however, patients with vitiligo may be enrolled; (patients with history of autoimmune thyroid conditions will be allowed as these patients will be on replacement medications)Xx_NEWLINE_xXPatients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligibleXx_NEWLINE_xXPatients with a history of autoimmune disease that require immunosuppressive medications at the time of screening are excludedXx_NEWLINE_xXPatients with autoimmune diseases that require immunosuppressive medications are excludedXx_NEWLINE_xXKnown autoimmune disease or presence of autoimmune phenomenaXx_NEWLINE_xXPatients with active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients must not have an active, known, or suspected autoimmune disease; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXSubjects with any active autoimmune disease or a history of known autoimmune diseaseXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease requiring treatmentXx_NEWLINE_xXAutoimmune disorders and other diseases that compromise or impair the immune system.Xx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease.Xx_NEWLINE_xXSubjects with any active or inactive autoimmune processXx_NEWLINE_xXSubjects with any active or inactive autoimmune processXx_NEWLINE_xXHas an active autoimmune disease.Xx_NEWLINE_xXActive or chronic autoimmune diseasesXx_NEWLINE_xXActive autoimmune disease (some exceptions include diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agentXx_NEWLINE_xXHistory of autoimmune disease.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.Xx_NEWLINE_xXSignificant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapyXx_NEWLINE_xXSubject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or auto-immune hepatitis. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXCurrent or history of systemic autoimmune disease requiring systemic therapy\r\n* Note: the following will NOT be exclusionary:\r\n** The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms\r\n** Clinical evidence of vitiligo or other forms of depigmenting illness\r\n** Mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis)Xx_NEWLINE_xXActive, known, or suspected autoimmune diseaseXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disease within 3 years with some exceptionsXx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXParticipant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXActive autoimmune disease.Xx_NEWLINE_xXActive or inactive autoimmune disease or syndrome.Xx_NEWLINE_xXSubjects who have known active autoimmune disease or a history of autoimmune disease which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids;Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHave any active autoimmune disease or a history of known or suspected autoimmune disease;Xx_NEWLINE_xXSubject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <=20 mg prednisolone or equivalent may be enrolled.Xx_NEWLINE_xXActive, known, or suspected autoimmune diseaseXx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXSignificant autoimmune disease, including active non-infectious pneumonitis, with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapyXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugsXx_NEWLINE_xXSubject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXPatients are ineligible if they have a history of autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapyXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXParticipants with active, known, or suspected autoimmune diseaseXx_NEWLINE_xXCurrent autoimmune disease or history of autoimmune disease with potential of CNS involvementXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease.Xx_NEWLINE_xXPatients with active autoimmune disease. (Patients with endocrine autoimmune diseases requiring replacement therapy alone are allowed.)Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.Xx_NEWLINE_xXHas active autoimmune disease.Xx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive, known, or suspected autoimmune disease or infectionXx_NEWLINE_xXActive known or suspected autoimmune disease with exceptions noted in protocol.Xx_NEWLINE_xXMedical history and concurrent diseases\r\n* Subjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\r\n* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXActive or prior autoimmune disease except for autoimmune thyroiditis, vitiligo, or psoriasis not requiring systemic therapyXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXNo history of autoimmune disordersXx_NEWLINE_xXKnown or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus or autoimmune vasculitis [e.g., Wegener’s granulomatosis] are excluded from this study; patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participateXx_NEWLINE_xXHistory of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of resultsXx_NEWLINE_xXPatients with active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXAutoimmune disease other than stable hypothyroidism or vitiligoXx_NEWLINE_xXHas an active autoimmune disease requiring immunosuppression with the exception of subjects with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease.Xx_NEWLINE_xXHistory of or known or suspected autoimmune disease (exception: vitiligo, resolved childhood atopic dermatitis, and history of Grave's disease that is euthyroid clinically and by laboratory testing at Screening)Xx_NEWLINE_xXActive autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseasesXx_NEWLINE_xXPresence or documented history of any of the following autoimmune conditions:Xx_NEWLINE_xXSubjects with active autoimmune diseases or history of autoimmune diseases should be excluded.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (e.g. Guillain-Barre syndrome). Patients with vitiligo are not excluded.Xx_NEWLINE_xXActive autoimmune disease requiring disease modifying therapyXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or a history of known or suspected autoimmune disease with the exception of subjects with isolated vitiligo, treated thyroiditis or resolved childhood asthma/atopyXx_NEWLINE_xXPatients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)Xx_NEWLINE_xXActive autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agentsXx_NEWLINE_xXPatients on immunosuppressive therapy or with immune system disorders, including autoimmune diseaseXx_NEWLINE_xXHistory or evidence of symptomatic autoimmune disease (such as pneumonitis, glomerulonephritis, vasculitis, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, scleroderma, or other), or history of autoimmune disease that required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. Replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes mellitus) is not considered a form of systemic treatment for autoimmune disease.Xx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXSubjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.Xx_NEWLINE_xXDONOR: Concurrent malignancy or autoimmune diseaseXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXPatients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.Xx_NEWLINE_xXSubjects who have any active or inactive autoimmune disease or syndrome.Xx_NEWLINE_xXHave an active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not on systemic treatment, or conditions not expected to recur in the absence of an external trigger.Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXActive known or suspected exclusionary autoimmune diseaseXx_NEWLINE_xXPatients with active autoimmune disease requiring disease-modifying therapy.Xx_NEWLINE_xXHistory of autoimmune hemolytic anemia or autoimmune thrombocytopenia.Xx_NEWLINE_xXAutoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemiaXx_NEWLINE_xXSubjects with active autoimmune disease requiring systemic immunosuppressive treatment within the past 4 weeks such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; a history of autoimmune disease which is not active nor has required recent systemic immunosuppressive therapy (< 4 weeks prior to enrollment) is not reason for exclusionXx_NEWLINE_xXPatients will be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.Xx_NEWLINE_xXActive, suspected or prior documented autoimmune disease.Xx_NEWLINE_xXPatients are excluded if they have an active, known or suspected autoimmune disease other than the following: vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, residual hypothyroidism due to autoimmune condition only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted to enrollXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome \r\nNOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with active known or suspected autoimmune disease (treated hypothyroidism is permitted to enroll)Xx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome; Note: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])Xx_NEWLINE_xXHistory of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen’s syndrome, vasculitis/arteritis, Behcet’s syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis; (vitiligo is allowed)Xx_NEWLINE_xXSystemic autoimmune disease (e.g., systemic lupus erythematosus, active rheumatoid arthritis, Marfan Syndrome, etc.).Xx_NEWLINE_xXAutoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatmentXx_NEWLINE_xXSubjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agentsXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapyXx_NEWLINE_xXThe participant has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.Xx_NEWLINE_xXActive, suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegner's granulomatosis, active Hashimoto's thyroiditis, rheumatoid arthritis, lupus, scleroderma and its variants, multiple sclerosis, myasthenia gravis). Vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted.Xx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXSubjects with active, known or suspected systemic autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with active autoimmune diseaseXx_NEWLINE_xXSubject with active, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXHistory of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccineXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders;Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXAny active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enrollXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders;Xx_NEWLINE_xXDiagnosis of autoimmune disease (i.e., rheumatoid arthritis, scleroderma, systemic lupus erythematosus [SLE], autoimmune vasculitis, Guillain-Barre syndrome, etc.), regardless if patient is currently receiving treatment at time of registration/randomizationXx_NEWLINE_xXPatients with significant autoimmune disease that is active or potentially life threatening if activatedXx_NEWLINE_xXSubject has active and uncontrolled autoimmune cytopeniaXx_NEWLINE_xXActive or prior autoimmune disease or history of immunodeficiency.Xx_NEWLINE_xXDiagnosis of autoimmune disease, including, but not limited to:\r\n* Systemic lupus erythematosus (lupus)\r\n* Multiple sclerosis (MS)\r\n* Rheumatoid arthritis (RA)\r\n* Ankylosing spondylitis\r\n* Other autoimmune disease (specify)Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive or prior autoimmune disease or history of immunodeficiencyXx_NEWLINE_xXPatients with existing autoimmune disorders (IL-2 and GM-CSF carry a theoretical clinical risk of exacerbating underlying autoimmune disorders)Xx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapyXx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXEvidence of active autoimmune disease (e.g., systemic lupus erythematosis, rheumatoid arthritis, with the exception of vitiligo. Patients with a remote history of asthma or mild asthma are eligible.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.Xx_NEWLINE_xXHistory of active autoimmune disordersXx_NEWLINE_xXAny active history of a known autoimmune disease; subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXParticipants with active, known, or suspected autoimmune diseaseXx_NEWLINE_xXActive or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.Xx_NEWLINE_xXKnown or suspected autoimmune disease, except for subjects with vitiligo, diabetes mellitus, resolved childhood asthma/atopy, residual hypothyroidism due to an autoimmune immune condition only requiring thyroid hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive autoimmune/inflammatory conditions requiring ongoing immunosuppressive therapyXx_NEWLINE_xXPatients with any clinically significant autoimmune disease requiring active treatmentXx_NEWLINE_xXPrior allogeneic transplant 7. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.Xx_NEWLINE_xXHistory of, or active autoimmune disease (such as autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjögrens syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, Crohn's or Graves' disease); patients with type 1 diabetes mellitus or vitiligo are not excluded if the condition is well controlledXx_NEWLINE_xXHistory of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusionXx_NEWLINE_xXSubjects with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease currently requiring therapyXx_NEWLINE_xXConcurrent major medical conditions, such as uncontrolled hypertension, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, autoimmune disease, adrenal insufficiency, or prior allogeneic organ transplant requiring chronic immunosuppressive therapy, including systemic glucocorticoid treatment or replacement therapyXx_NEWLINE_xXClinically active autoimmune disease.Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXPatients with a history of life-threatening autoimmune diseaseXx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXAny isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)Xx_NEWLINE_xXAny immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatmentXx_NEWLINE_xXSubjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enrollXx_NEWLINE_xXAny active known or suspected autoimmune diseaseXx_NEWLINE_xXPrevious clinical evidence of an autoimmune diseaseXx_NEWLINE_xXPatients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopeniaXx_NEWLINE_xXHistory of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte antigen 4 [CTLA-4]) therapy that has been completely resolved for more than 4 weeksXx_NEWLINE_xXHistory of severe autoimmune disease requiring steroids or other immunosuppressive treatmentsXx_NEWLINE_xXActive or history of autoimmune diseaseXx_NEWLINE_xXAutoimmune diseases or chronic decompensated diseasesXx_NEWLINE_xXAny active or history of a known autoimmune diseaseXx_NEWLINE_xXAny isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)Xx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolledXx_NEWLINE_xXPatients with a history of autoimmune diseases except for Hashimoto's thyroiditisXx_NEWLINE_xXPatients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)Xx_NEWLINE_xXActive, known, or suspected autoimmune disease within the past 2 years; NOTE: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; participants with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXPatients with a history of autoimmune hypothyroidism AND without normal thyroid hormone levels on a stable dose of thyroid replacement hormoneXx_NEWLINE_xXActive or history of any autoimmune disease (subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.Xx_NEWLINE_xXPatients with active autoimmune disease requiring disease-modifying therapy.Xx_NEWLINE_xXSubjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease are excludedXx_NEWLINE_xXActive autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;Xx_NEWLINE_xXPatients with uncontrolled autoimmune diseases.Xx_NEWLINE_xXHistory of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.Xx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXUncontrolled autoimmune hemolytic anemia or thrombocytopeniaXx_NEWLINE_xXExisting autoimmune cytopeniaXx_NEWLINE_xXHas an active or inactive autoimmune process.Xx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease.Xx_NEWLINE_xXAutoimmune disordersXx_NEWLINE_xXPatients whose life expectancy is severely limited by illness other than autoimmune diseaseXx_NEWLINE_xXDonor does not have concurrent malignancy or autoimmune diseaseXx_NEWLINE_xXDonor has evidence of concurrent malignancy or autoimmune diseaseXx_NEWLINE_xXAutoimmune diseases such as the following: autoimmune neutropenia, thrombocytopenia, hemolytic anemia, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome, Addison’s disease, Hashimoto’s thyroiditis, or active Graves’ diseaseXx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXPatients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.Xx_NEWLINE_xXDONOR: Autoimmune disease requiring immunosuppressive drugs for maintenanceXx_NEWLINE_xXActive autoimmune disease, history of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or history of known autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease or documented history of autoimmune disease.Xx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease.Xx_NEWLINE_xXPre-existing autoimmune or antibody mediated disease including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, Addison's disease, but excluding the presence of autoantibodies without clinical autoimmune diseaseXx_NEWLINE_xXPre-existing autoimmunity: history of inflammatory bowel disease; history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome); subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive autoimmune disease or condition requiring chronic immunosuppressive therapy (e.g., rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)\r\n* NOTE: abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionaryXx_NEWLINE_xXActive or uncontrolled autoimmune disease that may require corticosteroid therapy during studyXx_NEWLINE_xXUncontrolled autoimmune anemia or thrombocytopeniaXx_NEWLINE_xXConditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.Xx_NEWLINE_xXAny active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.)Xx_NEWLINE_xXActive autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (e.g.: +ANA, +RF, antithyroglobulin antibodies), or mild arthritis requiring no therapy or manageable with NSAIDs.Xx_NEWLINE_xXHistory of autoimmune diseasesXx_NEWLINE_xXPre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)Xx_NEWLINE_xXSuffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)Xx_NEWLINE_xXActive autoimmune disease or condition requiring chronic immunosuppressive therapyXx_NEWLINE_xXPatients with autoimmune hemolytic anemia or autoimmune thrombocytopenia will be eligible for treatmentXx_NEWLINE_xXPatients should be excluded if they have an active, known or suspected autoimmune disease; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive or inactive autoimmune process.Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disordersXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXPatients with active, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agentXx_NEWLINE_xXAutoimmune disease: history of or current active autoimmune diseases, (e.g. including but not limited to inflammatory bowel diseases [IBD], rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis [scleroderma and variants], systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies [such as Guillain-Barre syndrome; vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionary)Xx_NEWLINE_xXPatients will be excluded if they have an active, known or suspected autoimmune disease; autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome)\r\n* Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease except controlled, treated hypothyroidism or type I diabetesXx_NEWLINE_xXDiagnosis of autoimmune disordersXx_NEWLINE_xXAutoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj?gren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significantXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.Xx_NEWLINE_xXHistory of autoimmune diseasesXx_NEWLINE_xXPatient with an autoimmune conditionXx_NEWLINE_xXPatients with active autoimmune disease or history of transplantationXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXPatients with active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent.Xx_NEWLINE_xXPatients may not have any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids or immunosuppressive medications, except for syndromes which would not be expected to recur in the absence of an external trigger; subjects with vitiligo, type I diabetes mellitus, or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enrollXx_NEWLINE_xXActive autoimmune diseases requiring treatment or a history of autoimmune disease.Xx_NEWLINE_xXActive known auto-immune disease with the exception of autoimmune thyroiditis, vitiligo, and alopecia;Xx_NEWLINE_xXDocumented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatmentXx_NEWLINE_xXPatients with any active autoimmune disease or a condition that requires systemic corticosteroids or other immunosuppressive medications will be excluded; exceptions to this are subjects with vitiligo, type I diabetes mellitus and autoimmune thyroiditis only requiring hormone replacement, who will be permitted to enrollXx_NEWLINE_xXActive autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; however, patients with vitiligo or clinically stable autoimmune endocrine disease who are on appropriate replacement therapy (if such therapy is indicated) are eligibleXx_NEWLINE_xXActive or history of autoimmune diseaseXx_NEWLINE_xXKnown immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B, or Hepatitis C, or has taken an immunosuppressive agent within 4 weeks prior to the start of SL-701 treatment. Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Xx_NEWLINE_xXAutoimmune disease requiring immunosuppressive drugs for maintenanceXx_NEWLINE_xXDONOR: Autoimmune disease requiring immunosuppressive drugs for maintenanceXx_NEWLINE_xXKnown history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatmentXx_NEWLINE_xXCurrent autoimmune disease or history of autoimmune disease with potential CNS involvementXx_NEWLINE_xXHistory of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome); history of vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are allowedXx_NEWLINE_xXPatients are excluded if they have a history of autoimmune disease except controlled and stable autoimmune thyroiditis; the excluded autoimmune diseases include acute disseminated encephalomyelitis, Addison’s disease, alopecia universalis, ankylosing spondylitis, antiphospholipid antibody syndrome, aplastic anemia, asthma, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune hypoparathyroidism, autoimmune hypophysitis, autoimmune myocarditis, autoimmune oophoritis, autoimmune orchitis, autoimmune thrombocytopenic purpura, Behcet’s disease, bullous pemphigoid, celiac disease, chronic fatigue syndrome, chronic inflammatory demyelinating polyneuropathy, Churg-Strauss syndrome, Crohn’s disease, dermatomyositis, dysautonomia, eczema, epidermolysis bullosa acquisita, gestational pemphigoid, giant cell arteritis, Goodpasture’s syndrome, Graves’ disease, Guillain-Barre syndrome, Hashimoto’s disease-except as noted above, immunoglobulin A (IgA) nephropathy, inflammatory bowel disease, interstitial cystitis, Kawasaki’s disease, Lambert-Eaton myasthenia syndrome, lupus erythematosus, chronic Lyme disease, Meniere’s syndrome, Mooren’s ulcer, morphea, multiple sclerosis, myasthenia gravis, neuromyotonia, opsoclonus myoclonus syndrome, optic neuritis, Ord’s thyroiditis, pemphigus, pernicious anemia, polyarteritis nodosa, polyarthritis, polyglandular autoimmune syndrome, primary biliary cirrhosis, psoriasis, Reiter’s syndrome, rheumatoid arthritis, sarcoidosis, Sjogren’s syndrome, Stiff-Person syndrome, Takayasu’s arteritis, ulcerative colitis, Vogt-Koyanagi-Harada disease, vulvodynia, and Wegener’s granulomatosisXx_NEWLINE_xXActive autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs)Xx_NEWLINE_xXPrevious diagnosis of autoimmune disease (Exceptions: patients with autoimmune thyroiditis or vitiligo may be enrolled)Xx_NEWLINE_xXActive or history of autoimmune diseaseXx_NEWLINE_xXHistory of any of the following diseases: inflammatory bowel disease or any other autoimmune bowel disease; systemic lupus erythematosus; rheumatoid arthritis; or any autoimmune ocular diseases. Patients with active autoimmune disease or a history of autoimmune disease other than those mentioned above must be approved by the GSK medical monitorXx_NEWLINE_xXNo active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)Xx_NEWLINE_xXSubjects with any active autoimmune disease or a documented history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (e.g. Guillain-Barre syndrome), and multiple sclerosis; patients with vitiligo, asthma and diabetes are NOT excluded; final determination can be left to the discretion of the principal investigatorXx_NEWLINE_xXSubjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)Xx_NEWLINE_xXAutoimmune diseaseXx_NEWLINE_xXActive or history of autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease with caveats as specified in protocolXx_NEWLINE_xXActive autoimmune disease.Xx_NEWLINE_xXActive autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugsXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXPatients must not have active or history of clinically significant autoimmune disease, defined as requiring systemic therapy; type II diabetes, vitiligo, stable hypothyroidism, and thyroid disease well controlled with thyroid replacement will not be considered exclusion criteriaXx_NEWLINE_xXActive uncontrolled autoimmune disease or active inflammatory diseaseXx_NEWLINE_xXAny immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatmentXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive autoimmune haemolytic anemia.Xx_NEWLINE_xXActive autoimmune thrombocytopenia.Xx_NEWLINE_xXActive autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugsXx_NEWLINE_xXCurrent immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugsXx_NEWLINE_xXHistory of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4]) therapy that has completely resolved for a period of more than 4 weeksXx_NEWLINE_xXExcluded from Arm B:\r\n* Patients with a history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active autoimmune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with fhIL7 therapy\r\n* Corrected QT (QTc) prolongation defined as a QTc greater than or equal to 470 ms or a prior history of cardiovascular disease, arrhythmias, or significant electrocardiogram (ECG) abnormalitiesXx_NEWLINE_xXPatients with history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active auto-immune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with rhIL7 therapyXx_NEWLINE_xXActive or history of autoimmune disorders/conditions.Xx_NEWLINE_xXPrior history of uveitis or autoimmune inflammatory eye diseaseXx_NEWLINE_xXActive, known or suspected autoimmune disease.Xx_NEWLINE_xXActive, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs; Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external triggerXx_NEWLINE_xXHistory of or known or suspected autoimmune disease (exception[s]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)Xx_NEWLINE_xXHistory of severe autoimmune disorders requiring use of steroids or other immunosuppressivesXx_NEWLINE_xXActive autoimmune disease requiring disease modifying therapyXx_NEWLINE_xXHistory of serious autoimmune disease;Xx_NEWLINE_xXKnown active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapyXx_NEWLINE_xXActive, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapyXx_NEWLINE_xXActive autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidismXx_NEWLINE_xXSubjects with active, known or suspected autoimmune disease; subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXActive inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitisXx_NEWLINE_xXSubject has history of chronic or recurrent (within the last year prior to screening) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.Xx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immunostimulatory agent; patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive known or suspected autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease including: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis; patients with a history of autoimmune-related hypothyroidism on thyroid replacement hormone or those with autoimmune dermatologic conditions not requiring the use of prednisone > 10 mg or equivalent are eligibleXx_NEWLINE_xXAutoimmune diseaseXx_NEWLINE_xXPatients with active autoimmune conditions requiting systemic immunosuppressive therapy within the previous 5 years at not eligibleXx_NEWLINE_xXPatients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligibleXx_NEWLINE_xXPatients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn’s disease, autoimmune hepatitis, Wegener’s etc., are ineligibleXx_NEWLINE_xXPatients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligibleXx_NEWLINE_xXMajor medical conditions involving the immune system such as autoimmune and/or inflammatory diseasesXx_NEWLINE_xXActive autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.Xx_NEWLINE_xXSubjects with active autoimmune disease, symptoms or conditions; subjects with vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, asymptomatic laboratory evidence of autoimmune disease (e.g.: +antinuclear antibody [ANA], +rheumatoid factor [RF], antithyroglobulin antibodies), or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXSubjects with an active, known or suspected autoimmune disease are excludedXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligibleXx_NEWLINE_xXNOTE: patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)Xx_NEWLINE_xXFor Arms L (pembrolizumab) and M (nivolumab), subjects with an active, known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of or active autoimmune diseaseXx_NEWLINE_xXPatients with autoimmune diseaseXx_NEWLINE_xXPatients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 yearsXx_NEWLINE_xXActive systemic infection or autoimmune diseaseXx_NEWLINE_xXHistory of uncontrolled autoimmune disease or on active treatmentXx_NEWLINE_xXAny active autoimmune disease requiring treatment, with the exception of vitiligoXx_NEWLINE_xXKnown autoimmune diseaseXx_NEWLINE_xXRECIPIENT: Diagnosis with autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease requiring systemic immunosuppressive therapy (standard of care [SOC] GVHD prophylaxis is permitted)Xx_NEWLINE_xXIs being treated for diagnosed diabetes or autoimmune diseaseXx_NEWLINE_xXHistory of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome, Addison’s disease, Hashimoto’s thyroiditis, or Graves disease); persons with vitiligo are not excludedXx_NEWLINE_xXDocumented or suspected immunosuppressive disorder or autoimmune diseaseXx_NEWLINE_xXHistory of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome; persons with vitiligo are not excluded; Persons with well-controlled autoimmune endocrinopathies, e.g., diabetes mellitus, Graves’ disease, Hashimoto’s thyroiditis, Addison’s disease are not excluded; persons with well-controlled rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica are not excludedXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXReceiving active treatment for cancer or an autoimmune conditionXx_NEWLINE_xXAny prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)Xx_NEWLINE_xXKnown immunosuppressive disease, autoimmune conditions, and /or chronic viral infectionsXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiencyXx_NEWLINE_xXAny active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; subjects with vitiligo, controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy are permitted to enrollXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXAutoimmune diseases or immune deficiency diseaseXx_NEWLINE_xXCancer or autoimmune disease under treatment.Xx_NEWLINE_xXDiagnosis of immunodeficiency or active autoimmune condition.Xx_NEWLINE_xXSubjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medicationsXx_NEWLINE_xXActive autoimmune disease or documented history of autoimmune disease.Xx_NEWLINE_xXSubjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of investigational agent, except for the following. a. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible.Xx_NEWLINE_xXPatients with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents including systemic steroids within 7 days prior to registration, are ineligibleXx_NEWLINE_xXActive, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disordersXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligibleXx_NEWLINE_xXActive autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent; the following are not exclusions:\r\n* Patients with diabetes type I, vitiligo, hypo- or hyperthyroid diseases, or psoriasis not requiring systemic immunosuppressive treatment are eligibleXx_NEWLINE_xXHas an active autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune hepatitisXx_NEWLINE_xXActive or history of autoimmune diseaseXx_NEWLINE_xXSubjects with any active autoimmune disease or a history of known autoimmune diseaseXx_NEWLINE_xXHas active, known or suspected autoimmune disease.Xx_NEWLINE_xXActive, known or suspected autoimmune diseaseXx_NEWLINE_xXActive autoimmune diseaseXx_NEWLINE_xXHistory of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.Xx_NEWLINE_xXActive/uncontrolled autoimmune diseaseXx_NEWLINE_xXActive/uncontrolled autoimmune diseaseXx_NEWLINE_xXSubjects with active autoimmune disease, a history of known or suspected autoimmune disease or a history of a syndrome requiring systemic corticosteroids (> 10 mg daily of prednisone equivalent) except for the treatment of malignancy with the exception of:\r\n* Isolated vitiligo\r\n* Resolved childhood atopy\r\n* History of a positive antinuclear antibody (ANA) titer without associated symptoms or history of symptoms of an autoimmune disorder\r\n* Controlled thyroid disorders\r\n* Type I diabetes mellitus\r\n* Psoriasis, Sjogren’s syndrome, and arthropathies not requiring systemic treatment\r\n* Autoimmune diseases: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, autoimmune vasculitis, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excludedXx_NEWLINE_xXHas active, or suspected autoimmune disease or a history of known autoimmune disease, with the exception of: o Participants with vitiligo, type I diabetes mellitus, resolved childhood asthma/atopy, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.Xx_NEWLINE_xXHistory of autoimmune diseaseXx_NEWLINE_xXActive autoimmune disease, motor neuropathy considered of autoimmune origin, or other central nervous system autoimmune disease.Xx_NEWLINE_xXHistory of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment. (Parts C, D and E only).Xx_NEWLINE_xX