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+Active autoimmune disease requiring systemic treatment within the past three months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; exceptions include: subjects with vitiligo or resolved childhood asthma/atopy; subjects who require intermittent use of bronchodilators or local steroid injections, and subjects with hypothyroidism who are stable on hormone replacement or Sjogren’s syndrome are eligible for the study
+History of autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+People with autoimmune disease
+Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
+Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
+Patients must not have any known autoimmune disease
+Active known or suspected autoimmune disease
+History 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.
+History of autoimmune disease
+Has an active or inactive autoimmune process
+Patients 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.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic therapy or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Any 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)
+Ongoing or recent (within 5 years) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments;
+10. Active or prior documented autoimmune disease within the past 2 years. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded;
+History of autoimmune disease
+Active autoimmune disease requiring disease-modifying therapy at the time of Screening.
+Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
+Participants with active, known, or suspected autoimmune disease
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Active or prior autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
+History of autoimmune disease
+Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active or history of autoimmune disease or immune deficiency;
+History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy
+History of active autoimmune disorders
+History of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
+Active or history of autoimmune disease or immune deficiency
+Patients 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).
+Have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years.
+Active, known or suspected autoimmune disease
+The subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
+Active or prior documented autoimmune disease within the past 2 years. (Note: Patients with vitiligo, Grave disease, or psoriasis not requiring systemic treatment within the past 2 years are eligible.)
+Participant must not have an active or prior documented autoimmune disease in the last 2 years.
+Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
+Active known or suspected exclusionary autoimmune disease
+Patients with active, known or suspected autoimmune disease.
+Active autoimmune disease
+Subjects with an active, known, or suspected autoimmune disease
+Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis
+Active autoimmune disease
+History of autoimmune disease
+Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
+History of or active autoimmune disorders
+History of autoimmune disease
+Active autoimmune disease that has required systemic treatment in past 2 years
+History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other systemic autoimmune disease.
+Participants with any active autoimmune disease (Appendix 2) or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
+Active autoimmune disease that has required systemic treatment within the last 2 years.
+Active, known or suspected autoimmune disease
+History of symptomatic autoimmune disease
+Active autoimmune disease, or documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
+Active autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditis
+Active autoimmune disease
+Participants with active, known or suspected autoimmune disease
+Participants with active, known or suspected autoimmune disease
+Has an active autoimmune disease that has required systemic treatment in past 2 years.
+Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the trial.
+Has an active autoimmune disease that has required systemic treatment in past 2 years
+Active, known or suspected autoimmune disease
+Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy.
+Any active or inactive autoimmune disease or syndrome
+Active or prior documented autoimmune or inflammatory disorders.
+Active autoimmune disease that has required systemic treatment in past 2 years
+Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
+Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active 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)
+Active, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseases
+Active known or suspected autoimmune disease
+Active autoimmune disease or a history of severe autoimmune disease or syndrome
+Active or prior documented autoimmune disease within the past 2 years, including but not limited to systemic lupus erythematosus, sarcoidosis syndrome, or Wegener’s granulomatosis; NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded
+History of, active or suspicion of autoimmune disease
+Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
+Has an active autoimmune disease that has required systemic treatment in the past 2 years.
+Participants with active, known or suspected autoimmune disease
+History of autoimmune disease
+Active or history of autoimmune disease or immune deficiency
+Autoimmune disease that required systemic treatment
+History or risk of autoimmune disease
+Active autoimmune disease that has required systemic treatment in the past 2 years
+The participant has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
+EXCLUSION - INFUSION: Uncontrolled autoimmune disease needing systemic steroids or steroid sparing agents except for hypothyroidism or type I diabetes
+Active or history of autoimmune disease or immune deficiency
+Active autoimmune disease or a documented history of autoimmune disease.
+History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
+Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity
+Has active autoimmune disease that has required systemic treatment in past 2 years.
+Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with vitiligo, Graves’ disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded; patients with autoimmune endocrine disease adequately controlled with hormone replacement therapy are not excluded
+Active or known autoimmune disease
+Primary or secondary immunodeficiency (including immunosuppressive disease, autoimmune disease [including autoimmune endocrinopathies, such as hypothyroidism, and insulin dependent diabetes mellitus], or usage of immunosuppressive medications).
+Patients with chronic autoimmune disease(s) requiring systemic immunosuppression.
+Active, known or suspected autoimmune disease.
+History of autoimmune disease
+Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
+History 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 etiology
+Patients with an active, known or suspected autoimmune disease
+History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
+EXCLUSION CRITERIA FOR STRATUM C: Concurrent illness\r\n* Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n** Patients with vitiligo or resolved asthma/atopy\r\n** Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome \r\n* History of or ongoing pneumonitis or significant interstitial lung disease\r\n* Note: This would include non-infectious pneumonitis that required steroid use\r\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n** Exception to this is the presence of gastrointestinal polyps/adenomas and non-metastatic carcinomas, and history of any previous malignancies in patients with CMMRD which will be allowed in this study\r\n* Patients who have received a solid organ transplant
+Study 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 excluded
+History of autoimmune disease
+History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
+Participants 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.
+Patients with any active autoimmune disease
+Patients with autoimmune disease
+Clinically active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE]) requiring treatment; vitiligo, diabetes, or treated thyroiditis are allowed
+Presence of autoimmune disease that requires corticosteroids and/or immunosuppressive agents.
+Systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma)
+History of major organ autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement will not be excluded from the study
+Subject has active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment.
+Active or history of autoimmune disease or immune deficiency;
+Active autoimmune disease requiring immunosuppressive therapy
+An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
+Active or prior documented autoimmune disease within the past 2 years (NOTE: The following are exceptions to this criterion: Participants with vitiligo or alopecia; Participants with hypothyroidism (e.g. following Hashimoto syndrome) who are stable on hormone replacement; Participants with celiac disease controlled by diet alone: Participants with Grave’s disease, or any chronic skin condition not requiring systemic treatment. Participants without active disease in the last 5 years may be included but only after consultation with the study physician.
+Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
+Participants must not have an active, known, or suspected autoimmune disease
+History of clinically significant autoimmune disease including active, known, or suspected autoimmune disease. Subjects with resolved side effects from prior checkpoint inhibitor therapy, vitiligo, psoriasis, type 1 diabetes or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded. Subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded.
+History of autoimmune disease
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Active autoimmune condition requiring systemic immunosuppressive medication
+Developed 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.
+Patients cannot have active autoimmune disease or immunosuppressive conditions
+Has active or prior documented autoimmune disease within the past 2 years with the exceptions of vitiligo, Grave's disease, and/or psoriasis not requiring systemic treatment
+Active or prior documented autoimmune or inflammatory disorders
+Autoimmune 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 significant
+Has an active autoimmune disease that has required systemic treatment in past 2 years
+Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing
+Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation
+Participants with active, known or suspected autoimmune disease
+History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
+Patients 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
+Uncontrolled autoimmune disease requiring active systemic treatment
+Active or history of autoimmune disease or immune deficiency
+Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
+Patients 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.
+Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
+Active or prior documented autoimmune or inflammatory disease with some exceptions
+History of or current active autoimmune diseases
+Patients/subjects with autoimmune disease
+Active known or suspected autoimmune disease
+Active known or suspected autoimmune disease
+Participants with chronic autoimmune diseases
+History of autoimmune disease
+Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this rule; patients who require intermittent use of bronchodilators or local steroid injections are not excluded from the study; patients with hypothyroidism stable on hormone replacement are not excluded from the study
+Active autoimmune disease requiring immunosuppressive therapy
+Active or history of autoimmune disease or immune deficiency
+Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Has an active autoimmune disease that has required systemic treatment in past 2 years.
+Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
+An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
+Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Active autoimmune disease or a history of severe autoimmune disease or syndrome
+No 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.
+Autoimmune 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 medications
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Active autoimmune disease requiring ongoing systemic immunosuppressive therapy
+Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
+History of major organ autoimmune disease.
+Active, known, or suspected autoimmune disease
+Active 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 investigator
+Patients with history of or active autoimmune disease including thyroiditis, colitis, nephritis, neuropathy or pneumonitis
+Has an active autoimmune disease that requires systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections are NOT excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome are NOT excluded from the study
+History of severe autoimmune disease
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave’s disease, limited site eczema, or limited site plaque psoriasis not requiring systemic treatment (within the past 2 years), or other autoimmune conditions which are not expected to recur, are allowed after approval from the medical monitor or principal investigator (PI)
+Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with a history of autoimmune thyroid disease are not excluded; subjects with vitiligo or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Participants with chronic autoimmune disease
+Has 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 toxicity
+Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >= 20 mg.
+Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
+Patients should not have an autoimmune disorder that requires active immunosuppression
+clinical history, prior diagnosis, or overt evidence of autoimmune disease
+History 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).
+History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders
+Active or history of medically significant autoimmune disease
+History of autoimmune disease
+No active autoimmune disease or a history of known or suspected autoimmune disease except as detailed in the exclusion criteria below
+Participants with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
+Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active or prior documented autoimmune disease within the past 2 years.\r\n* NOTE: Subjects with vitiligo, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy > 20 mg prednisone daily or equivalent, within 7 days of starting venetoclax
+FOR ALL PHASES (Ib AND II): History of, or current autoimmune disease
+Active autoimmune disease requiring systemic immunosuppressive therapy.
+Active autoimmune disease requiring systemic immune suppressive treatment within the past 2 years; NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Patients with chronic autoimmune disease
+Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: Active autoimmune disease requiring immunosuppressive therapy, unless considered by the PI or designee to be eligible
+Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome are not excluded from the study
+Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Patients with active known autoimmune disease are ineligible
+Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; NOTES: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Patients 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).
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Active uncontrolled autoimmune cytopenias
+Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
+Active autoimmune disease requiring immunosuppressive therapy
+History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years
+History 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.
+Active or chronic autoimmune diseases
+Patients/subjects with autoimmune disease
+Active, known, or suspected autoimmune disease or infection
+Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
+Ongoing 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 events
+History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
+Subjects with active, known, or suspected autoimmune disease are excluded
+Active or prior documented autoimmune disease within the past 2 years\r\n* NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires chronic systemic steroids or immunosuppressive agents except as noted above; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Active autoimmune diseases requiring systemic treatments
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Has active or prior documented autoimmune disease within the past 2 years with the exceptions of vitiligo, Grave’s disease, and/or psoriasis not requiring systemic treatment
+Active 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/atopy
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study.
+Active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents; Note: patients with the conditions or medical history listed below are NOT excluded from this study\r\n* Vitiligo\r\n* Resolved childhood asthma/atopy\r\n* Requirement for intermittent use of bronchodilators or local steroid injections or topical steroids\r\n* Hypothyroidism stable on hormone replacement\r\n* Sjogren's syndrome
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
+Patients 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 weeks
+History 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 recruitment
+Has an active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism, interstitial lung disease, colitis
+Patients with significant autoimmune disease that is active or potentially life threatening if activated
+Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Has an active autoimmune disease, or a documented history of autoimmune disease that required systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be exception to this rule; subjects that require inhaled steroid or local steroid injections will not be excluded from the study; subjects with hypothyroidism not from autoimmune disease and stable on hormone replacement will not be excluded from the study
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
+Patients 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 exclusionary
+Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
+Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
+History of major organ autoimmune disease
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active or prior documented history of immunologic disorder including autoimmune disease within the past 2 years NOTE: subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Those with active autoimmune disease are excluded from the study
+Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or equivalent
+Active or prior documented autoimmune disease within the past 2 years; NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+The 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* Vitiligo
+Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications; exceptions include those with vitiligo or resolved childhood asthma/atopy; subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule, and are eligible; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease requiring immunosuppressive therapy
+EXCLUSION CRITERIA FOR TNBC: Active autoimmune disease requiring immunosuppressive therapy
+Active autoimmune disease requiring disease-modifying therapy
+Active autoimmune disease.
+Autoimmune 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 exclusionary
+Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Has a diagnosis of severe active scleroderma, lupus, other rheumatologic or autoimmune disease within the past 3 months; patients with a documented history of clinically severe autoimmune disease or a syndrome requiring systemic steroids or immunosuppressive agents will not be allowed on this study; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study; subjects with hypothyroidism stable on hormone replacement are not excluded from this study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study; subjects that have adrenal or pituitary insufficiency that require physiologic corticosteroid replacement therapy would not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+History of severe autoimmune disease requiring steroids or other immunosuppressive treatments
+Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy
+History of major organ autoimmune disease
+Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
+Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+History of autoimmune disease(s)
+Subjects with active, known or suspected autoimmune or immunosuppressive disease.
+Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjögren’s syndrome will not be excluded from the study; any autoimmune diagnoses not listed here must be approved by the protocol chair
+Ongoing or recent significant autoimmune disease
+Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
+Has active autoimmune disease that has required systemic treatment in past 2 years
+Active autoimmune disease that has required systemic treatment in the past 2 years
+Patients 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 considered
+Autoimmune disease
+History of active autoimmune disease
+Participants with active, known or suspected autoimmune disease
+Must not have active autoimmune disease (see protocol for exceptions)
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study; subjects with hypophysitis stable on physiologic dose of steroid will not be excluded from the study
+Patients with a history of life-threatening autoimmune disease
+History of chronic inflammatory or autoimmune disease
+Active 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.
+Known autoimmune disease
+History of prior or current autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Subject has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; note: subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+No active autoimmune disease or a history of known or suspected autoimmune disease
+Active 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 enrolled
+Known history of HIV or autoimmune diseases requiring immunosuppressant drugs
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement
+Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome are not excluded from the study
+History 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 stable
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis
+Active autoimmune disease within the past 2 years, except for mild conditions not requiring systemic treatment, such as vitiligo
+Mild 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 system
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Patients with active autoimmune disease or history of transplantation; patients with indolent or chronic autoimmune disease not requiring steroid treatment are considered eligible
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
+Patient has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo, type I diabetes, resolved childhood asthma/atopy would be exceptions to this rule; patients who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement will also not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of inhaled steroids or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Evidence 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.
+Pre-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 study
+Patients 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 participation
+Active life-threatening autoimmune disease
+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\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 eligible
+RANDOMIZED 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 eligible
+Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI)
+Immuosuppressive disorders (chronic steroid therapy, acquired or congenital immune deficiency syndromes, autoimmune disease)
+Patients with known active autoimmune disorder
+DONOR: History of autoimmune disease
+No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)
+Has active, known, or suspected autoimmune disease
+Participants with active, known or suspected autoimmune disease
+Active or inactive autoimmune process.
+Active autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:
+Has active or prior autoimmune disease within the past 2 years
+Active autoimmune or auto-inflammatory ocular disease within 6 months
+Known or suspected active organ-threatening autoimmune disease
+Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
+Patients with an active autoimmune disease
+History of autoimmune disease as detailed above
+Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).
+Active, known or suspected autoimmune disease
+Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
+Subject has an active autoimmune disease that has required systemic treatment within the past 2 years.
+An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
+Patients with active or documented history of autoimmune disease;
+Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
+Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
+Active autoimmune disease or documented history of autoimmune disease.
+Any active autoimmune disease
+Known autoimmune disease requiring active treatment.
+Active/prior autoimmune of inflammatory disorders
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Active autoimmune disease or a documented history of autoimmune disease.
+Patients with active autoimmune anemia or autoimmune thrombocytopenia are NOT eligible
+Active autoimmune disease
+Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
+Must not have been diagnosed with autoimmune disease or be immunosuppressed
+Previous or concurrent evidence of autoimmune disease requiring systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require inhaled steroid or local steroid injections will not be excluded from the study. Subjects with hypothyroidism who are stable on hormone replacement will not be excluded from the study.
+Active autoimmune disease prior to transplant
+Active or inactive autoimmune disease or syndrome that has required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease.
+Have history of uncontrolled autoimmune disease.
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Autoimmune disorder
+Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Patients with known active autoimmune disorder
+History of autoimmune disease
+No history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)
+Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
+History of major organ autoimmune disease
+Significant 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.
+Patient has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement will not be excluded from the study
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Known current or prior autoimmune disease with the exception of vitiligo
+Active or prior documented autoimmune disease; subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Immunosuppressed patients (cancer, autoimmune disease) or patients taking immunosuppressive drugs
+Has active autoimmune disease or history of transplantation
+Has autoimmune hepatitis
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
+Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n* Patients with vitiligo or well controlled asthma/atopy\r\n* Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome
+Any active, known or suspected autoimmune disease
+Patients with active, known or suspected autoimmune disease
+Active or history of autoimmune disease or immune deficiency
+Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
+Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
+Subjects with active, known or suspected autoimmune disease
+Patients are not eligible who have a history of or active autoimmune disease within the past 3 years with the following exceptions:\r\n* Vitiligo or alopecia\r\n* Hypothyroidism on stable doses of thyroid replacement therapy\r\n* Psoriasis not requiring systemic therapy within the past 3 years
+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 eligible
+The 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 dysfunction
+Patients that have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive agents; subjects with vitiligo, type I diabetes mellitus, or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active or prior documented autoimmune disease within the past 2 years\r\n* NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+History of, or current autoimmune disease
+Patients 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)
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an example of an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; those with a history of hypothyroidism who are now stable on hormone replacement will not be excluded; those with Sjorgen’s syndrome will not be excluded from the study
+Patients with a history of autoimmune disease requiring continuous treatment
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Subjects with a history of known autoimmune disease are excluded from this study
+Participants 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) medications
+Autoimmune disease
+Current 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 illness
+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 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 eligible
+Patients 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 enroll
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; Note: subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would NOT be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will NOT be excluded from the trial
+Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis
+Patients 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 splenectomy
+Participants 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 excluded
+Active 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)
+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 (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 eligible
+Patients with a history of autoimmune disease that require immunosuppressive medications at the time of screening are excluded
+Known autoimmune disease or presence of autoimmune phenomena
+Any known pre-existing autoimmune disorder
+Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
+Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
+History of autoimmune disorder (e.g. hepatitis)
+Patients with active, known or suspected autoimmune disease
+Active autoimmune disease that has required systemic treatment in past 2 years
+Subjects must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, steroids or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression.
+Subjects with any active autoimmune disease or a history of known autoimmune disease
+Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents.
+Subjects with active, known or suspected autoimmune disease
+Active autoimmune disease
+Active autoimmune disease or a documented history of autoimmune disease
+Active autoimmune disease requiring treatment
+Autoimmune disorders and other diseases that compromise or impair the immune system.
+Has an active autoimmune disease that has required systemic treatment in past 2 years
+Subjects with an active, known or suspected autoimmune disease.
+Active autoimmune disease requiring systemic treatment in past 2 years.
+Active autoimmune disease that has required systemic treatment in past 2 years
+Ongoing 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 events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
+Subjects with any active or inactive autoimmune process
+Subjects with any active or inactive autoimmune process
+Active or prior documented autoimmune disease within the past 2 years
+Has an active autoimmune disease.
+Active or chronic autoimmune diseases
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Has an active autoimmune disease that has required systemic treatment in the past 2 years.
+Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
+Active autoimmune disease that required systemic treatment in the past 2 years
+History of autoimmune disease.
+Subjects with active, known or suspected autoimmune disease
+Significant 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
+History of autoimmune disease
+Current 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)
+Active, known, or suspected autoimmune disease
+Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
+Active, known or suspected autoimmune disease
+Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents
+Active autoimmune disease requiring systemic treatment within the past 2 years
+Active or history of autoimmune disease or immune deficiency
+Active autoimmune disease.
+Active or inactive autoimmune disease or syndrome.
+Has an active autoimmune disease requiring systemic treatment within the past 2 years OR a documented history of clinically severe autoimmune disease.
+Subjects 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;
+Active, known or suspected autoimmune disease
+Has active autoimmune disease that has required systemic treatment in past 2 years.
+History of any autoimmune disease which required systemic therapy in the past 2 years
+History of autoimmune disease
+Have any active autoimmune disease or a history of known or suspected autoimmune disease;
+Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
+Active or prior documented autoimmune disease within the last 2 years.
+History of autoimmune disease
+Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
+Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <=20 mg prednisolone or equivalent may be enrolled.
+Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years.
+Active autoimmune disease requiring therapy within the past 2 years (Note: patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are not excluded);
+Active, known, or suspected autoimmune disease
+Active, known or suspected autoimmune disease
+Significant 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 therapy
+History of autoimmune disease
+Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
+Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
+History of autoimmune disease
+Participants with active, known, or suspected autoimmune disease
+Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
+History of autoimmune disease
+Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease.
+Patients with active autoimmune disease. (Patients with endocrine autoimmune diseases requiring replacement therapy alone are allowed.)
+History of autoimmune disease
+History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
+Has active autoimmune disease.
+No autoimmune disorder that requires active immunosuppression
+Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Active autoimmune disease that has required systemic treatment in past 2 years.
+Subjects with active, known or suspected autoimmune disease
+Active, known, or suspected autoimmune disease or infection
+Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
+Active known or suspected autoimmune disease with exceptions noted in protocol.
+Active or prior autoimmune disease except for autoimmune thyroiditis, vitiligo, or psoriasis not requiring systemic therapy
+Subjects with active, known or suspected autoimmune disease
+Active or prior documented autoimmune disease within the past 2 years (Note: subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment [within the past 2 years] are not excluded)
+No history of autoimmune disorders
+History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
+Patients with active, known or suspected autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Autoimmune disease other than stable hypothyroidism or vitiligo
+Has 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.
+History 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)
+Presence or documented history of any of the following autoimmune conditions:
+Motor neuropathy considered of autoimmune origin
+Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
+Has an active auto-immune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopia would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+History of autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+History 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.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease requiring disease modifying therapy
+Active autoimmune disease that has required systemic treatment in past 2 years
+Active autoimmune disease requiring systemic treatment in the past 2 years
+Has active autoimmune disease that has required treatment in the past 2 years.
+Subjects with active, known or suspected autoimmune disease
+Active 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/atopy
+Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
+Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
+Patients on immunosuppressive therapy or with immune system disorders, including autoimmune disease
+History 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.
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
+Active autoimmune disease
+Subjects who have any active or inactive autoimmune disease or syndrome.
+Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
+Active autoimmune disease that required systemic treatment in the past. Patients who have not required systemic treatment for at least two years may be enrolled if permission is provided after discussion with the Medical Monitor.
+Active, known or suspected autoimmune disease
+Active known or suspected autoimmune disease
+Active known or suspected exclusionary autoimmune disease
+Patients with active autoimmune disease requiring disease-modifying therapy.
+History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
+Patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved chilhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
+History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents; participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren’s syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (=< 10 mg/d) are not excluded from this study
+Subjects 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 exclusion
+Active, known, suspected autoimmune disease requiring systemic treatment in the past 2 years
+Active or prior documented autoimmune or inflammatory disorders within the past 3 years.
+Active, suspected or prior documented autoimmune disease.
+Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
+Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Patients with active known or suspected autoimmune disease (treated hypothyroidism is permitted to enroll)
+Has active or prior documented autoimmune disease within the past 24 months
+Has active autoimmune disease that has required systemic treatment within the 2 years prior to the first dose of study medication
+Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Subjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents
+Patient has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism that is stable on hormone replacement will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
+Active autoimmune disease that has required systemic treatment in past 2 years .
+Known history of an autoimmune disorder
+Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
+Active autoimmune disease requiring systemic treatment in past 2 years
+The participant has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Patients with active autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study
+Subject with active, known or suspected autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions to the rule: subjects with vitiligo; subjects with resolved childhood asthma/atopy; subjects that require intermittent use of bronchodilators or local steroid injections; subjects with hypothyroidism stable on hormone replacement or patients with Sjögren's syndrome
+Active autoimmune disease that has required systemic treatment in past 2 years
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active or prior documented autoimmune disease within the past 2 years
+Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease that has required systemic treatment in past 2 years
+History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
+Active or prior documented autoimmune or inflammatory disorders;
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; a severe autoimmune disease is one that requires a significant medical intervention such as hospitalization; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+History of autoimmune disease
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators, topical steroids or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Patient has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; the use of physiologic doses of corticosteroids may be approved after consultation with the protocol principal investigator (PI) and Cancer Immunotherapy Trials Network (CITN); patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents
+Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
+Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
+Active or prior documented autoimmune disease within the past 2 years.
+Active or prior documented autoimmune or inflammatory disorders;
+Diagnosis 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/randomization
+Patients with significant autoimmune disease that is active or potentially life threatening if activated
+Subject has active and uncontrolled autoimmune cytopenia
+Active or prior autoimmune disease or history of immunodeficiency.
+History of autoimmune disease
+Subjects with active, known or suspected autoimmune disease
+Active or prior autoimmune disease or history of immunodeficiency
+Patients with existing autoimmune disorders (IL-2 and GM-CSF carry a theoretical clinical risk of exacerbating underlying autoimmune disorders)
+Active autoimmune disease requiring systemic immunosuppressive therapy
+Known history of an autoimmune disorder
+Active, known or suspected autoimmune disease
+Subjects with active, known or suspected autoimmune disease
+Evidence 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.
+History of autoimmune disease
+Active, known or suspected autoimmune disease
+History of autoimmune disease
+Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.
+History of active autoimmune disorders
+Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.
+Active or history of autoimmune disease or immune deficiency
+Participants with active, known, or suspected autoimmune disease
+Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
+Active autoimmune/inflammatory conditions requiring ongoing immunosuppressive therapy
+Patients with any clinically significant autoimmune disease requiring active treatment
+Prior allogeneic transplant 7. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
+History 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 controlled
+Subjects with active, known or suspected autoimmune disease
+Active autoimmune disease currently requiring therapy
+Clinically active autoimmune disease.
+Active, known or suspected autoimmune disease
+Patients with a history of life-threatening autoimmune disease
+Active or prior documented autoimmune disease within the past 2 years
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
+Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
+Any active known or suspected autoimmune disease
+Previous clinical evidence of an autoimmune disease
+Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
+History 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 weeks
+History of severe autoimmune disease requiring steroids or other immunosuppressive treatments
+Active or history of autoimmune disease
+Any active or history of a known autoimmune disease
+Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
+Active autoimmune disease
+History of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolled
+Known immunosuppression (i.e. chronic steroid use) or autoimmune disorder
+Has an active autoimmune disease that requires systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule; subjects who require intermittent use of bronchodilators or local steroid injections are NOT excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome are NOT excluded from the study
+Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
+Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
+Autoimmune disease that has required systemic treatment in past 2 years
+Has an active autoimmune disease that has required systemic treatment in past 2 years
+Active or prior documented autoimmune disease within the past 2 years; Note: subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded; rare exceptions allowed with the consent of both principal investigators (Drs. Lee and Sherman)
+Patients with active autoimmune disease requiring disease-modifying therapy.
+Active or prior documented autoimmune disease within the past 2 years NOTE: subjects with vitiligo, Graves disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Subjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
+Active, known or suspected autoimmune disease
+Subjects with an active, known or suspected autoimmune disease are excluded
+Active or prior documented active autoimmune disease that has required systemic treatment; NOTE: Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded; patients with celiac disease controlled with diet modification are not excluded
+Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
+Patients with uncontrolled autoimmune diseases.
+History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
+Existing autoimmune cytopenia
+Has an active or inactive autoimmune process.
+Active autoimmune disease or a documented history of autoimmune disease.
+Autoimmune disorders
+Patients whose life expectancy is severely limited by illness other than autoimmune disease
+Has an active autoimmune disease that has required systemic treatment in past 2 years
+Active autoimmune disease that has required systemic treatment in the past 3 months.
+Autoimmune 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’ disease
+Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+DONOR: Autoimmune disease requiring immunosuppressive drugs for maintenance
+History of or active systemic autoimmune disorder or immunodeficiency syndromes
+Active autoimmune disease, history of autoimmune disease
+Active autoimmune disease or history of known autoimmune disease
+Active autoimmune disease or documented history of autoimmune disease.
+Active autoimmune disease or a documented history of autoimmune disease.
+Pre-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 disease
+Active or prior documented autoimmune disease within the past 3 years
+Active 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 exclusionary
+History of therapy for an autoimmune disorder
+Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
+Uncontrolled autoimmune anemia or thrombocytopenia
+Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
+Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.)
+Active 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.
+History of autoimmune diseases
+Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
+Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
+Active autoimmune disease or condition requiring chronic immunosuppressive therapy
+Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia will be eligible for treatment
+Active or inactive autoimmune process.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
+Active or prior documented autoimmune or inflammatory disorders
+Patients with active, known or suspected autoimmune disease
+Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
+Autoimmune 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)
+Active autoimmune disease
+Diagnosis of autoimmune disorders
+Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj?gren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
+Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
+History of autoimmune diseases
+Patient with an autoimmune condition
+Patients with active autoimmune disease or history of transplantation
+History of autoimmune disease
+Active autoimmune diseases requiring treatment or a history of autoimmune disease.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects who require intermittent use of inhaled steroids or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic therapy (within the past 3 years) will not be excluded from the study
+Active known auto-immune disease with the exception of autoimmune thyroiditis, vitiligo, and alopecia;
+Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
+Has active autoimmune disease or a documented history of autoimmune disease, or history of potential autoimmune syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo, endocrinopathies, type 1 diabetes, or patients with resolved childhood asthma/atopy or other syndromes which would not be expected to recur in the absence of an external trigger (e.g., drug-related serum sickness or post-streptococcal glomerulonephritis). Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) who have not been hospitalized for asthma in the preceding 3 years will not be excluded from this study.
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; the use of physiologic doses of corticosteroids may be approved after consultation with the protocol principal investigator (PI) and Cancer Immunotherapy Trials Network (CITN); patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active 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 eligible
+Active or history of autoimmune disease
+Autoimmune disease requiring immunosuppressive drugs for maintenance
+DONOR: Autoimmune disease requiring immunosuppressive drugs for maintenance
+Active or prior documented autoimmune disease within the past 2 years
+Active or prior documented autoimmune disease within the past 2 years
+Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
+Current autoimmune disease or history of autoimmune disease with potential CNS involvement
+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); history of vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are allowed
+Patients 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 granulomatosis
+Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs)
+Previous diagnosis of autoimmune disease (Exceptions: patients with autoimmune thyroiditis or vitiligo may be enrolled)
+Active or history of autoimmune disease
+History 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 monitor
+Subjects 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 investigator
+Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
+Autoimmune disease
+Active or history of autoimmune disease
+Active or prior autoimmune disorder within the past 2 years
+History of autoimmune disease with caveats as specified in protocol
+Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
+Active autoimmune disease.
+Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
+History of autoimmune disease
+Any active autoimmune disease or documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo, psoriasis inactive within past 2 years, resolved childhood asthma/atopy, or thyroid disease controlled by replacement therapy without the need for immunosuppression
+History of autoimmune disease
+Patients 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 criteria
+Active uncontrolled autoimmune disease or active inflammatory disease
+Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
+History of autoimmune disease
+Active autoimmune haemolytic anemia.
+Active autoimmune thrombocytopenia.
+Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
+Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs
+History 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 weeks
+Excluded 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) abnormalities
+Active or history of autoimmune disorders/conditions.
+Active, known or suspected autoimmune disease.
+History 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)
+Active or prior documented autoimmune disease within the past 2 years; patients with a history of vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
+Active autoimmune disease requiring disease modifying therapy
+History of serious autoimmune disease;
+Known active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
+Active, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy
+Subject 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.
+Active known or suspected autoimmune disease
+Autoimmune disease
+Patients with active autoimmune conditions requiting systemic immunosuppressive therapy within the previous 5 years at not eligible
+Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
+Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
+Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
+History of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
+Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.
+Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and pembrolizumab only)
+Subjects with an active, known or suspected autoimmune disease are excluded
+History of autoimmune disease
+History of or active autoimmune disease
+Patients with autoimmune disease
+Active systemic infection or autoimmune disease
+History of uncontrolled autoimmune disease or on active treatment
+Any active autoimmune disease requiring treatment, with the exception of vitiligo
+Known autoimmune disease
+RECIPIENT: Diagnosis with autoimmune disease
+Active autoimmune disease requiring systemic immunosuppressive therapy (standard of care [SOC] GVHD prophylaxis is permitted)
+Is being treated for diagnosed diabetes or autoimmune disease
+History 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 excluded
+Documented or suspected immunosuppressive disorder or autoimmune disease
+Patients with serious, concomitant disorder, including active systemic infection, autoimmune disease, proven or suspected immunosuppressive disorder or any other major medical illnesses of the cardiovascular or respiratory system, concurrent malignancy except for nonmelanoma skin lesions
+History 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 excluded
+History of autoimmune disease
+Receiving active treatment for cancer or an autoimmune condition
+Subjects with systemic autoimmune disorder;
+Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)
+Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections
+Active or history of autoimmune disease or immune deficiency
+History of autoimmune disease
+History of autoimmune disease
+Autoimmune diseases or immune deficiency disease
+Cancer or autoimmune disease under treatment.
+Diagnosis of immunodeficiency or active autoimmune condition.
+Subjects 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
+Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
+Active autoimmune disease or documented history of autoimmune disease.
+Has an active autoimmune disease that has required systemic treatment in past 2 years.
+Autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
+Patients with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents including systemic steroids within 7 days prior to registration, are ineligible
+Active or prior documented autoimmune or inflammatory disorders
+Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
+Has an active autoimmune disease
+History of autoimmune hepatitis
+Active or history of autoimmune disease
+Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that requires concomitant use of chronic systemic corticosteroids or other immunosuppressive medications, except for subjects with vitiligo, treated thyroiditis or resolved asthma/atopy.
+Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
+Subjects with any active autoimmune disease or a history of known autoimmune disease
+Has active, known or suspected autoimmune disease.
+Active, known or suspected autoimmune disease
+Active autoimmune disease
+History 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.
+Active/uncontrolled autoimmune disease
+Active autoimmune disease that required systemic treatment in the past.
+Active/uncontrolled autoimmune disease
+Subjects 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 excluded
+History of autoimmune disease
+Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.
+Active autoimmune disease that required systemic treatment in the past 2 years
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren’s syndrome will not be excluded from the study
+Active autoimmune disease, motor neuropathy considered of autoimmune origin, or other central nervous system autoimmune disease.
+History 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).
+Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease even if resolved; patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; patients with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study