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a b/clusters/3009knumclusters/clust_162.txt
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Active autoimmune disease requiring systemic treatment within the past three months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; exceptions include: subjects with vitiligo or resolved childhood asthma/atopy; subjects who require intermittent use of bronchodilators or local steroid injections, and subjects with hypothyroidism who are stable on hormone replacement or Sjogren’s syndrome are eligible for the study
2
History of autoimmune disease
3
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
4
People with autoimmune disease
5
Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
6
Patients with autoimmune disease who are otherwise eligible must not have received steroid and immunosuppressive therapy within 28 days prior to registration
7
Patients must not have any known autoimmune disease
8
Active known or suspected autoimmune disease
9
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.
10
History of autoimmune disease
11
Has an active or inactive autoimmune process
12
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.
13
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
14
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)
15
Ongoing or recent (within 5 years) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments;
16
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;
17
History of autoimmune disease
18
Active autoimmune disease requiring disease-modifying therapy at the time of Screening.
19
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
20
Participants with active, known, or suspected autoimmune disease
21
Active autoimmune disease that has required systemic treatment in past 2 years.
22
Active or prior autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
23
History of autoimmune disease
24
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
25
Active or history of autoimmune disease or immune deficiency;
26
History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy
27
History of active autoimmune disorders
28
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.
29
Active or history of autoimmune disease or immune deficiency
30
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).
31
Have active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents in the past 2 years.
32
Active, known or suspected autoimmune disease
33
The subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
34
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.)
35
Participant must not have an active or prior documented autoimmune disease in the last 2 years.
36
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.
37
Active known or suspected exclusionary autoimmune disease
38
Patients with active, known or suspected autoimmune disease.
39
Active autoimmune disease
40
Subjects with an active, known, or suspected autoimmune disease
41
Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis
42
Active autoimmune disease
43
History of autoimmune disease
44
Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
45
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
46
History of or active autoimmune disorders
47
History of autoimmune disease
48
Active autoimmune disease that has required systemic treatment in past 2 years
49
History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other systemic autoimmune disease.
50
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.
51
Active autoimmune disease that has required systemic treatment within the last 2 years.
52
Active, known or suspected autoimmune disease
53
History of symptomatic autoimmune disease
54
Active autoimmune disease, or documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
55
Active autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditis
56
Active autoimmune disease
57
Participants with active, known or suspected autoimmune disease
58
Participants with active, known or suspected autoimmune disease
59
Has an active autoimmune disease that has required systemic treatment in past 2 years.
60
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.
61
Has an active autoimmune disease that has required systemic treatment in past 2 years
62
Active, known or suspected autoimmune disease
63
Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy.
64
Any active or inactive autoimmune disease or syndrome
65
Active or prior documented autoimmune or inflammatory disorders.
66
Active autoimmune disease that has required systemic treatment in past 2 years
67
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
68
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
69
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)
70
Active, known, or suspected immunosuppressive disorders, such as acquired or congenital immune deficiency syndromes and autoimmune diseases
71
Active known or suspected autoimmune disease
72
Active autoimmune disease or a history of severe autoimmune disease or syndrome
73
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
74
History of, active or suspicion of autoimmune disease
75
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.
76
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
77
Participants with active, known or suspected autoimmune disease
78
History of autoimmune disease
79
Active or history of autoimmune disease or immune deficiency
80
Autoimmune disease that required systemic treatment
81
History or risk of autoimmune disease
82
Active autoimmune disease that has required systemic treatment in the past 2 years
83
The participant has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
84
EXCLUSION - INFUSION: Uncontrolled autoimmune disease needing systemic steroids or steroid sparing agents except for hypothyroidism or type I diabetes
85
Active or history of autoimmune disease or immune deficiency
86
Active autoimmune disease or a documented history of autoimmune disease.
87
History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
88
Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity
89
Has active autoimmune disease that has required systemic treatment in past 2 years.
90
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
91
Active or known autoimmune disease
92
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).
93
Patients with chronic autoimmune disease(s) requiring systemic immunosuppression.
94
Active, known or suspected autoimmune disease.
95
History of autoimmune disease
96
Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
97
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
98
Patients with an active, known or suspected autoimmune disease
99
History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
100
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
101
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
102
History of autoimmune disease
103
History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
104
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.
105
Patients with any active autoimmune disease
106
Patients with autoimmune disease
107
Clinically active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE]) requiring treatment; vitiligo, diabetes, or treated thyroiditis are allowed
108
Presence of autoimmune disease that requires corticosteroids and/or immunosuppressive agents.
109
Systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma)
110
History of major organ autoimmune disease
111
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
112
Subject has active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment.
113
Active or history of autoimmune disease or immune deficiency;
114
Active autoimmune disease requiring immunosuppressive therapy
115
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
116
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.
117
Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
118
Participants must not have an active, known, or suspected autoimmune disease
119
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.
120
History of autoimmune disease
121
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
122
Active autoimmune condition requiring systemic immunosuppressive medication
123
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.
124
Patients cannot have active autoimmune disease or immunosuppressive conditions
125
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
126
Active or prior documented autoimmune or inflammatory disorders
127
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
128
Has an active autoimmune disease that has required systemic treatment in past 2 years
129
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
130
Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation
131
Participants with active, known or suspected autoimmune disease
132
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
133
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
134
Uncontrolled autoimmune disease requiring active systemic treatment
135
Active or history of autoimmune disease or immune deficiency
136
Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
137
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.
138
Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
139
Active or prior documented autoimmune or inflammatory disease with some exceptions
140
History of or current active autoimmune diseases
141
Patients/subjects with autoimmune disease
142
Active known or suspected autoimmune disease
143
Active known or suspected autoimmune disease
144
Participants with chronic autoimmune diseases
145
History of autoimmune disease
146
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
147
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
148
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
149
Active autoimmune disease requiring immunosuppressive therapy
150
Active or history of autoimmune disease or immune deficiency
151
Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
152
Active autoimmune disease that has required systemic treatment in past 2 years.
153
Has an active autoimmune disease that has required systemic treatment in past 2 years.
154
Subjects with active autoimmune disease or a syndrome that requires systemic corticosteroids
155
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
156
Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
157
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
158
Active autoimmune disease or a history of severe autoimmune disease or syndrome
159
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.
160
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
161
Active autoimmune disease requiring systemic immunosuppressive therapy
162
Active autoimmune disease requiring ongoing systemic immunosuppressive therapy
163
Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
164
History of major organ autoimmune disease.
165
Active, known, or suspected autoimmune disease
166
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
167
Patients with history of or active autoimmune disease including thyroiditis, colitis, nephritis, neuropathy or pneumonitis
168
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
169
History of severe autoimmune disease
170
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)
171
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
172
Active autoimmune disease requiring systemic immunosuppressive therapy
173
Participants with chronic autoimmune disease
174
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
175
Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >= 20 mg.
176
Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
177
Patients should not have an autoimmune disorder that requires active immunosuppression
178
clinical history, prior diagnosis, or overt evidence of autoimmune disease
179
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).
180
History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders
181
Active or history of medically significant autoimmune disease
182
History of autoimmune disease
183
No active autoimmune disease or a history of known or suspected autoimmune disease except as detailed in the exclusion criteria below
184
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.
185
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
186
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
187
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
188
FOR ALL PHASES (Ib AND II): History of, or current autoimmune disease
189
Active autoimmune disease requiring systemic immunosuppressive therapy.
190
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
191
Patients with chronic autoimmune disease
192
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
193
CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: Active autoimmune disease requiring immunosuppressive therapy, unless considered by the PI or designee to be eligible
194
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
195
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
196
Patients with active known autoimmune disease are ineligible
197
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
198
Active autoimmune disease requiring systemic immunosuppressive therapy
199
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).
200
Active autoimmune disease requiring systemic immunosuppressive therapy
201
Active uncontrolled autoimmune cytopenias
202
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.
203
Active autoimmune disease requiring immunosuppressive therapy
204
History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years
205
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.
206
Active or chronic autoimmune diseases
207
Patients/subjects with autoimmune disease
208
Active, known, or suspected autoimmune disease or infection
209
Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
210
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
211
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.
212
Subjects with active, known, or suspected autoimmune disease are excluded
213
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
214
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
215
Active autoimmune diseases requiring systemic treatments
216
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
217
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
218
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
219
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.
220
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
221
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
222
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
223
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
224
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
225
Has an active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism, interstitial lung disease, colitis
226
Patients with significant autoimmune disease that is active or potentially life threatening if activated
227
Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
228
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
229
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
230
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
231
Autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
232
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
233
Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
234
Active autoimmune disease and chronic inflammatory conditions requiring concurrent use of any systemic immunosuppressants or steroids.
235
History of major organ autoimmune disease
236
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
237
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
238
Those with active autoimmune disease are excluded from the study
239
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
240
Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or equivalent
241
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
242
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
243
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
244
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
245
Active autoimmune disease requiring immunosuppressive therapy
246
EXCLUSION CRITERIA FOR TNBC: Active autoimmune disease requiring immunosuppressive therapy
247
Active autoimmune disease requiring disease-modifying therapy
248
Active autoimmune disease.
249
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
250
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
251
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
252
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
253
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
254
History of severe autoimmune disease requiring steroids or other immunosuppressive treatments
255
Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy
256
History of major organ autoimmune disease
257
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
258
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
259
History of autoimmune disease(s)
260
Subjects with active, known or suspected autoimmune or immunosuppressive disease.
261
Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
262
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
263
Ongoing or recent significant autoimmune disease
264
Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
265
Has active autoimmune disease that has required systemic treatment in past 2 years
266
Active autoimmune disease that has required systemic treatment in the past 2 years
267
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
268
Autoimmune disease
269
History of active autoimmune disease
270
Participants with active, known or suspected autoimmune disease
271
Must not have active autoimmune disease (see protocol for exceptions)
272
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
273
Patients with a history of life-threatening autoimmune disease
274
History of chronic inflammatory or autoimmune disease
275
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.
276
Known autoimmune disease
277
History of prior or current autoimmune disease
278
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
279
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
280
Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
281
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
282
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.
283
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
284
No active autoimmune disease or a history of known or suspected autoimmune disease
285
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
286
Known history of HIV or autoimmune diseases requiring immunosuppressant drugs
287
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
288
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
289
Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
290
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
291
Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement
292
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
293
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
294
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
295
History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis
296
Active autoimmune disease within the past 2 years, except for mild conditions not requiring systemic treatment, such as vitiligo
297
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
298
Active autoimmune disease requiring systemic immunosuppressive therapy
299
Patients with active autoimmune disease or history of transplantation; patients with indolent or chronic autoimmune disease not requiring steroid treatment are considered eligible
300
Active autoimmune disease requiring systemic immunosuppressive therapy
301
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy
302
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
303
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
304
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.
305
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
306
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
307
Active life-threatening autoimmune disease
308
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
309
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
310
Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the Principal Investigator (PI)
311
Immuosuppressive disorders (chronic steroid therapy, acquired or congenital immune deficiency syndromes, autoimmune disease)
312
Patients with known active autoimmune disorder
313
DONOR: History of autoimmune disease
314
No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)
315
Has active, known, or suspected autoimmune disease
316
Participants with active, known or suspected autoimmune disease
317
Active or inactive autoimmune process.
318
Active autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:
319
Has active or prior autoimmune disease within the past 2 years
320
Active autoimmune or auto-inflammatory ocular disease within 6 months
321
Known or suspected active organ-threatening autoimmune disease
322
Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
323
Patients with an active autoimmune disease
324
History of autoimmune disease as detailed above
325
Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).
326
Active, known or suspected autoimmune disease
327
Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
328
Subject has an active autoimmune disease that has required systemic treatment within the past 2 years.
329
An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
330
Patients with active or documented history of autoimmune disease;
331
Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
332
Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
333
Active autoimmune disease or documented history of autoimmune disease.
334
Any active autoimmune disease
335
Known autoimmune disease requiring active treatment.
336
Active/prior autoimmune of inflammatory disorders
337
Active autoimmune disease requiring systemic immunosuppressive therapy
338
Active autoimmune disease or a documented history of autoimmune disease.
339
Patients with active autoimmune anemia or autoimmune thrombocytopenia are NOT eligible
340
Active autoimmune disease
341
Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
342
Must not have been diagnosed with autoimmune disease or be immunosuppressed
343
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.
344
Active autoimmune disease prior to transplant
345
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.
346
Have history of uncontrolled autoimmune disease.
347
Active autoimmune disease that has required systemic treatment in past 2 years.
348
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
349
Autoimmune disorder
350
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.
351
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
352
Patients with known active autoimmune disorder
353
History of autoimmune disease
354
No history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)
355
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
356
History of major organ autoimmune disease
357
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.
358
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
359
Active autoimmune disease requiring systemic immunosuppressive therapy
360
Known current or prior autoimmune disease with the exception of vitiligo
361
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
362
Immunosuppressed patients (cancer, autoimmune disease) or patients taking immunosuppressive drugs
363
Has active autoimmune disease or history of transplantation
364
Has autoimmune hepatitis
365
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.
366
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
367
Any active, known or suspected autoimmune disease
368
Patients with active, known or suspected autoimmune disease
369
Active or history of autoimmune disease or immune deficiency
370
Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
371
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
372
Subjects with active, known or suspected autoimmune disease
373
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
374
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)
375
Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
376
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
377
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
378
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
379
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
380
History of, or current autoimmune disease
381
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)
382
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
383
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
384
Patients with a history of autoimmune disease requiring continuous treatment
385
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
386
Subjects with a history of known autoimmune disease are excluded from this study
387
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
388
Autoimmune disease
389
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
390
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
391
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
392
Active autoimmune disease requiring systemic immunosuppressive therapy
393
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
394
Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis
395
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
396
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
397
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)
398
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
399
Patients with a history of autoimmune disease that require immunosuppressive medications at the time of screening are excluded
400
Known autoimmune disease or presence of autoimmune phenomena
401
Any known pre-existing autoimmune disorder
402
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
403
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
404
History of autoimmune disorder (e.g. hepatitis)
405
Patients with active, known or suspected autoimmune disease
406
Active autoimmune disease that has required systemic treatment in past 2 years
407
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.
408
Subjects with any active autoimmune disease or a history of known autoimmune disease
409
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.
410
Subjects with active, known or suspected autoimmune disease
411
Active autoimmune disease
412
Active autoimmune disease or a documented history of autoimmune disease
413
Active autoimmune disease requiring treatment
414
Autoimmune disorders and other diseases that compromise or impair the immune system.
415
Has an active autoimmune disease that has required systemic treatment in past 2 years
416
Subjects with an active, known or suspected autoimmune disease.
417
Active autoimmune disease requiring systemic treatment in past 2 years.
418
Active autoimmune disease that has required systemic treatment in past 2 years
419
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.
420
Subjects with any active or inactive autoimmune process
421
Subjects with any active or inactive autoimmune process
422
Active or prior documented autoimmune disease within the past 2 years
423
Has an active autoimmune disease.
424
Active or chronic autoimmune diseases
425
Active autoimmune disease that has required systemic treatment in past 2 years.
426
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
427
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
428
Active autoimmune disease that required systemic treatment in the past 2 years
429
History of autoimmune disease.
430
Subjects with active, known or suspected autoimmune disease
431
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
432
History of autoimmune disease
433
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)
434
Active, known, or suspected autoimmune disease
435
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
436
Active, known or suspected autoimmune disease
437
Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents
438
Active autoimmune disease requiring systemic treatment within the past 2 years
439
Active or history of autoimmune disease or immune deficiency
440
Active autoimmune disease.
441
Active or inactive autoimmune disease or syndrome.
442
Has an active autoimmune disease requiring systemic treatment within the past 2 years OR a documented history of clinically severe autoimmune disease.
443
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;
444
Active, known or suspected autoimmune disease
445
Has active autoimmune disease that has required systemic treatment in past 2 years.
446
History of any autoimmune disease which required systemic therapy in the past 2 years
447
History of autoimmune disease
448
Have any active autoimmune disease or a history of known or suspected autoimmune disease;
449
Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
450
Active or prior documented autoimmune disease within the last 2 years.
451
History of autoimmune disease
452
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.
453
Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <=20 mg prednisolone or equivalent may be enrolled.
454
Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years.
455
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);
456
Active, known, or suspected autoimmune disease
457
Active, known or suspected autoimmune disease
458
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
459
History of autoimmune disease
460
Active or history of any autoimmune disease (except for subjects with vitiligo) or immunodeficiencies that required treatment with systemic immunosuppressive drugs
461
Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
462
History of autoimmune disease
463
Participants with active, known, or suspected autoimmune disease
464
Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
465
History of autoimmune disease
466
Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease.
467
Patients with active autoimmune disease. (Patients with endocrine autoimmune diseases requiring replacement therapy alone are allowed.)
468
History of autoimmune disease
469
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.
470
Has active autoimmune disease.
471
No autoimmune disorder that requires active immunosuppression
472
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
473
Active autoimmune disease that has required systemic treatment in past 2 years.
474
Active autoimmune disease that has required systemic treatment in past 2 years.
475
Active autoimmune disease that has required systemic treatment in past 2 years.
476
Subjects with active, known or suspected autoimmune disease
477
Active, known, or suspected autoimmune disease or infection
478
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
479
Active known or suspected autoimmune disease with exceptions noted in protocol.
480
Active or prior autoimmune disease except for autoimmune thyroiditis, vitiligo, or psoriasis not requiring systemic therapy
481
Subjects with active, known or suspected autoimmune disease
482
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)
483
No history of autoimmune disorders
484
History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
485
Patients with active, known or suspected autoimmune disease
486
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
487
Autoimmune disease other than stable hypothyroidism or vitiligo
488
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.
489
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)
490
Presence or documented history of any of the following autoimmune conditions:
491
Motor neuropathy considered of autoimmune origin
492
Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
493
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
494
History of autoimmune disease
495
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
496
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.
497
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
498
Active autoimmune disease requiring disease modifying therapy
499
Active autoimmune disease that has required systemic treatment in past 2 years
500
Active autoimmune disease requiring systemic treatment in the past 2 years
501
Has active autoimmune disease that has required treatment in the past 2 years.
502
Subjects with active, known or suspected autoimmune disease
503
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
504
Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
505
Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
506
Patients on immunosuppressive therapy or with immune system disorders, including autoimmune disease
507
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.
508
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
509
Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
510
Active autoimmune disease
511
Subjects who have any active or inactive autoimmune disease or syndrome.
512
Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
513
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.
514
Active, known or suspected autoimmune disease
515
Active known or suspected autoimmune disease
516
Active known or suspected exclusionary autoimmune disease
517
Patients with active autoimmune disease requiring disease-modifying therapy.
518
History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
519
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
520
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
521
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
522
Active, known, suspected autoimmune disease requiring systemic treatment in the past 2 years
523
Active or prior documented autoimmune or inflammatory disorders within the past 3 years.
524
Active, suspected or prior documented autoimmune disease.
525
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.
526
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
527
Patients with active known or suspected autoimmune disease (treated hypothyroidism is permitted to enroll)
528
Has active or prior documented autoimmune disease within the past 24 months
529
Has active autoimmune disease that has required systemic treatment within the 2 years prior to the first dose of study medication
530
Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
531
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
532
Subjects with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents
533
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
534
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
535
Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
536
Active autoimmune disease that has required systemic treatment in past 2 years .
537
Known history of an autoimmune disorder
538
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
539
Active autoimmune disease requiring systemic treatment in past 2 years
540
The participant has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
541
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
542
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
543
Patients with active autoimmune disease
544
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
545
Subject with active, known or suspected autoimmune disease
546
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
547
Active autoimmune disease that has required systemic treatment in past 2 years
548
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
549
Active or prior documented autoimmune disease within the past 2 years
550
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
551
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
552
Active autoimmune disease that has required systemic treatment in past 2 years
553
History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
554
Active or prior documented autoimmune or inflammatory disorders;
555
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
556
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
557
History of autoimmune disease
558
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
559
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
560
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
561
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
562
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
563
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
564
Active or prior documented autoimmune disease within the past 2 years.
565
Active or prior documented autoimmune or inflammatory disorders;
566
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
567
Patients with significant autoimmune disease that is active or potentially life threatening if activated
568
Subject has active and uncontrolled autoimmune cytopenia
569
Active or prior autoimmune disease or history of immunodeficiency.
570
History of autoimmune disease
571
Subjects with active, known or suspected autoimmune disease
572
Active or prior autoimmune disease or history of immunodeficiency
573
Patients with existing autoimmune disorders (IL-2 and GM-CSF carry a theoretical clinical risk of exacerbating underlying autoimmune disorders)
574
Active autoimmune disease requiring systemic immunosuppressive therapy
575
Known history of an autoimmune disorder
576
Active, known or suspected autoimmune disease
577
Subjects with active, known or suspected autoimmune disease
578
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.
579
History of autoimmune disease
580
Active, known or suspected autoimmune disease
581
History of autoimmune disease
582
Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.
583
History of active autoimmune disorders
584
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.
585
Active or history of autoimmune disease or immune deficiency
586
Participants with active, known, or suspected autoimmune disease
587
Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
588
Active autoimmune/inflammatory conditions requiring ongoing immunosuppressive therapy
589
Patients with any clinically significant autoimmune disease requiring active treatment
590
Prior allogeneic transplant 7. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
591
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
592
Subjects with active, known or suspected autoimmune disease
593
Active autoimmune disease currently requiring therapy
594
Clinically active autoimmune disease.
595
Active, known or suspected autoimmune disease
596
Patients with a history of life-threatening autoimmune disease
597
Active or prior documented autoimmune disease within the past 2 years
598
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
599
Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
600
Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
601
Any active known or suspected autoimmune disease
602
Previous clinical evidence of an autoimmune disease
603
Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
604
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
605
History of severe autoimmune disease requiring steroids or other immunosuppressive treatments
606
Active or history of autoimmune disease
607
Any active or history of a known autoimmune disease
608
Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g. hypothyroidism)
609
Active autoimmune disease
610
History of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolled
611
Known immunosuppression (i.e. chronic steroid use) or autoimmune disorder
612
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
613
Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
614
Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP)
615
Autoimmune disease that has required systemic treatment in past 2 years
616
Has an active autoimmune disease that has required systemic treatment in past 2 years
617
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)
618
Patients with active autoimmune disease requiring disease-modifying therapy.
619
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
620
Subjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
621
Active, known or suspected autoimmune disease
622
Subjects with an active, known or suspected autoimmune disease are excluded
623
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
624
Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
625
Patients with uncontrolled autoimmune diseases.
626
History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
627
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
628
Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
629
Existing autoimmune cytopenia
630
Has an active or inactive autoimmune process.
631
Active autoimmune disease or a documented history of autoimmune disease.
632
Autoimmune disorders
633
Patients whose life expectancy is severely limited by illness other than autoimmune disease
634
Has an active autoimmune disease that has required systemic treatment in past 2 years
635
Active autoimmune disease that has required systemic treatment in the past 3 months.
636
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
637
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
638
DONOR: Autoimmune disease requiring immunosuppressive drugs for maintenance
639
History of or active systemic autoimmune disorder or immunodeficiency syndromes
640
Active autoimmune disease, history of autoimmune disease
641
Active autoimmune disease or history of known autoimmune disease
642
Active autoimmune disease or documented history of autoimmune disease.
643
Active autoimmune disease or a documented history of autoimmune disease.
644
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
645
Active or prior documented autoimmune disease within the past 3 years
646
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
647
History of therapy for an autoimmune disorder
648
Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
649
Uncontrolled autoimmune anemia or thrombocytopenia
650
Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
651
Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.)
652
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.
653
History of autoimmune diseases
654
Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
655
Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
656
Active autoimmune disease or condition requiring chronic immunosuppressive therapy
657
Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia will be eligible for treatment
658
Active or inactive autoimmune process.
659
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.
660
Active or prior documented autoimmune or inflammatory disorders
661
Patients with active, known or suspected autoimmune disease
662
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
663
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)
664
Active autoimmune disease
665
Diagnosis of autoimmune disorders
666
Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj?gren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
667
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
668
History of autoimmune diseases
669
Patient with an autoimmune condition
670
Patients with active autoimmune disease or history of transplantation
671
History of autoimmune disease
672
Active autoimmune diseases requiring treatment or a history of autoimmune disease.
673
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
674
Active known auto-immune disease with the exception of autoimmune thyroiditis, vitiligo, and alopecia;
675
Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
676
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.
677
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
678
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
679
Active or history of autoimmune disease
680
Autoimmune disease requiring immunosuppressive drugs for maintenance
681
DONOR: Autoimmune disease requiring immunosuppressive drugs for maintenance
682
Active or prior documented autoimmune disease within the past 2 years
683
Active or prior documented autoimmune disease within the past 2 years
684
Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
685
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
686
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
687
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
688
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs)
689
Previous diagnosis of autoimmune disease (Exceptions: patients with autoimmune thyroiditis or vitiligo may be enrolled)
690
Active or history of autoimmune disease
691
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
692
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
693
Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
694
Autoimmune disease
695
Active or history of autoimmune disease
696
Active or prior autoimmune disorder within the past 2 years
697
History of autoimmune disease with caveats as specified in protocol
698
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
699
Active autoimmune disease.
700
Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
701
History of autoimmune disease
702
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
703
History of autoimmune disease
704
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
705
Active uncontrolled autoimmune disease or active inflammatory disease
706
Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
707
History of autoimmune disease
708
Active autoimmune haemolytic anemia.
709
Active autoimmune thrombocytopenia.
710
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
711
Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs
712
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
713
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
714
Active or history of autoimmune disorders/conditions.
715
Active, known or suspected autoimmune disease.
716
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)
717
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
718
History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
719
Active autoimmune disease requiring disease modifying therapy
720
History of serious autoimmune disease;
721
Known active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy
722
Active, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy
723
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.
724
Active known or suspected autoimmune disease
725
Autoimmune disease
726
Patients with active autoimmune conditions requiting systemic immunosuppressive therapy within the previous 5 years at not eligible
727
Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
728
Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible
729
Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
730
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
731
Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.
732
Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and pembrolizumab only)
733
Subjects with an active, known or suspected autoimmune disease are excluded
734
History of autoimmune disease
735
History of or active autoimmune disease
736
Patients with autoimmune disease
737
Active systemic infection or autoimmune disease
738
History of uncontrolled autoimmune disease or on active treatment
739
Any active autoimmune disease requiring treatment, with the exception of vitiligo
740
Known autoimmune disease
741
RECIPIENT: Diagnosis with autoimmune disease
742
Active autoimmune disease requiring systemic immunosuppressive therapy (standard of care [SOC] GVHD prophylaxis is permitted)
743
Is being treated for diagnosed diabetes or autoimmune disease
744
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
745
Documented or suspected immunosuppressive disorder or autoimmune disease
746
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
747
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
748
History of autoimmune disease
749
Receiving active treatment for cancer or an autoimmune condition
750
Subjects with systemic autoimmune disorder;
751
Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease)
752
Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections
753
Active or history of autoimmune disease or immune deficiency
754
History of autoimmune disease
755
History of autoimmune disease
756
Autoimmune diseases or immune deficiency disease
757
Cancer or autoimmune disease under treatment.
758
Diagnosis of immunodeficiency or active autoimmune condition.
759
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
760
Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
761
Active autoimmune disease or documented history of autoimmune disease.
762
Has an active autoimmune disease that has required systemic treatment in past 2 years.
763
Autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
764
Patients with known immunodeficiency, known autoimmune disease, or concurrent use of immunomodulatory agents including systemic steroids within 7 days prior to registration, are ineligible
765
Active or prior documented autoimmune or inflammatory disorders
766
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.
767
Has an active autoimmune disease
768
History of autoimmune hepatitis
769
Active or history of autoimmune disease
770
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.
771
Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
772
Subjects with any active autoimmune disease or a history of known autoimmune disease
773
Has active, known or suspected autoimmune disease.
774
Active, known or suspected autoimmune disease
775
Active autoimmune disease
776
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.
777
Active/uncontrolled autoimmune disease
778
Active autoimmune disease that required systemic treatment in the past.
779
Active/uncontrolled autoimmune disease
780
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
781
History of autoimmune disease
782
Have history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years.
783
Active autoimmune disease that required systemic treatment in the past 2 years
784
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
785
Active autoimmune disease, motor neuropathy considered of autoimmune origin, or other central nervous system autoimmune disease.
786
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).
787
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