Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody [ANA], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
People with autoimmune disease
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-) therapy that has been completely resolved for more than weeks prior to CD.
Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 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).
Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis
History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other systemic autoimmune disease.
Active autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditis
Patients with an autoimmune disorder of the central or peripheral nervous system will be eligible; this will include:\r\n* Primary Central Nervous System (CNS) vasculitis\t\r\n* Rasmussens encephalitis\r\n* Autoimmune peripheral neuropathy (anti-Hu [Anna-], anti-GM [GDb], anti-MAG, anti-ganglioside, anti-sulfatide)\r\n* Autoimmune cerebellar degeneration\r\n* Gait Ataxia with Late age Onset Polyneuropathy (GALOP)\r\n* Stiff Person Syndrome\r\n* Chronic Inflammatory Demyelinating Polyneuropathy\r\n* Myasthenia Gravis\r\n* Lambert-Eaton myasthenic syndrome\r\n* Human T-cell lymphotropic virus (HTLV)--associated myelopathy (HAM) / tropical spastic paraparesis (TSP)\r\n* Opsoclonus / myoclonus (anti-Ri)\r\n* Neuromyelitis optica\t\r\n* Multiple sclerosis (only patients with relapsing/remitting multiple sclerosis [MS] will be included)\r\n* Other central or peripheral nervous system autoimmune diseases as approved by study neurologists and the Fred Hutchinson Cancer Research Center (FHCRC) faculty at Patient Care Conference (PCC)
DONOR: Concordant for autoimmune neurological disease(s) as determined by neurological evaluation
Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)
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
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).
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, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome, Addisons disease, Hashimotos 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 diabetes are not excluded if the condition is well controlled:\r\n** Hemoglobin AC < ., and\r\n** No evidence of end-organ damage due to diabetes, such as diabetic retinopathy, nephropathy, or neuropathy\r\n** Persons with type 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
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.
Developed autoimmune disorders of Grade while on prior immunotherapy. Subjects who developed autoimmune disorders, of Grade ? may enroll if the disorder has resolved to Grade ? and the subject has been off systemic steroids at doses > mg/day, for the treatment of the autoimmune disorder, for at least weeks.
Any diagnosis of autoimmune disease (confirmed by medical records or appropriate laboratory testing)
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
Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease\r\n** Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n** Patients with diabetes type I, vitiligo, or alopecia are allowed\r\n* Other immunodeficiency diseases\r\n* Splenectomy
Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
Patients with laboratory evidence of autoimmune disease (e.g. positive antinuclear antibody [ANA] or lupus anticoagulant) without associated symptoms; vitiligo, or mild autoimmunity not impacting the function of organs, such as Hashimoto or psoriasis may be eligible for study
Patients with history of or active autoimmune disease including thyroiditis, colitis, nephritis, neuropathy or pneumonitis
clinical history, prior diagnosis, or overt evidence of autoimmune disease
History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders
FOR ALL PHASES (Ib AND II): History of, or current autoimmune disease
Patients with history of mild autoimmune disorders - including but not limited to - mild psoriasis or Hashimoto's hypothyroidism, may be included at the discretion of the principle investigator.
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 uncontrolled autoimmune cytopenias
Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
Autoimmune diseases such as rheumatoid arthritis are NOT allowed; vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed
History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible; use of immunosuppressant drugs such as systemic steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc.: systemic use is not permitted within weeks before recruitment
Patients with a recent history (within last 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 > 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\n 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
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Graves disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases
Ongoing or recent significant autoimmune disease
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 diabetes mellitus\r\n** Residual hypothyroidism due to autoimmune condition only requiring hormone replacement\r\n** Euthyroid participants with a history of Graves 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
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.
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
History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis
Mild autoimmune conditions (such as localized psoriasis) requiring minimal treatment or systemic autoimmune conditions well controlled by target agents such as an anti-IL- that do not affect overall immune system
No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)
Must not have been diagnosed with autoimmune disease or be immunosuppressed
Autoimmune disorder
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.
Known current or prior autoimmune disease with the exception of vitiligo
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 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)
Patients with a history of autoimmune disease requiring continuous treatment
Participants that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the weeks ( 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
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 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
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)
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
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)
No evidence of any systemic autoimmune disease (e.g. Hashimotos thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
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;
Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <= mg prednisolone or equivalent may be enrolled.
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
Patients with active autoimmune disease. (Patients with endocrine autoimmune diseases requiring replacement therapy alone are allowed.)
Active or prior autoimmune disease except for autoimmune thyroiditis, vitiligo, or psoriasis not requiring systemic therapy
Autoimmune disease other than stable hypothyroidism or vitiligo
Presence or documented history of any of the following autoimmune conditions:
Known chronic liver disease, autoimmune hepatitis, or sclerosing cholangitis
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases\r\n* Splenectomy
Subjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents
Active liver disease, for example, due to autoimmune hepatic disorder, or sclerosing cholangitis
History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
Subject has active and uncontrolled autoimmune cytopenia
Known liver disease, autoimmune hepatitis, or sclerosing cholangitis.
Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases
Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
Previous clinical evidence of an autoimmune disease
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte antigen [CTLA-]) therapy that has been completely resolved for more than weeks
Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
History of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolled
Existing autoimmune cytopenia
History of or active systemic autoimmune disorder or immunodeficiency syndromes
Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
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.
Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
Patient with an autoimmune condition
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
Previous diagnosis of autoimmune disease (Exceptions: patients with autoimmune thyroiditis or vitiligo may be enrolled)
Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte-associated antigen [CTLA-]) therapy that has completely resolved for a period of more than 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-hIL; patients with a history of B cell malignancy due to a risk for growth with fhIL therapy\r\n* Corrected QT (QTc) prolongation defined as a QTc greater than or equal to ms or a prior history of cardiovascular disease, arrhythmias, or significant electrocardiogram (ECG) abnormalities
Active or history of autoimmune disorders/conditions.
Prior history of uveitis or autoimmune inflammatory eye disease
History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
Any active autoimmune disease requiring treatment, with the exception of vitiligo
RECIPIENT: Diagnosis with autoimmune disease
Receiving active treatment for cancer or an autoimmune condition
Subjects with systemic autoimmune disorder;
History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators
Developed autoimmune disorders of Grade while on prior immunotherapy. Subjects who developed autoimmune disorders of Grade ? may enroll if the disorder has resolved to Grade ? and the subject has been off systemic steroids at doses > mg/day for at least weeks.