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