Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and systemic mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 6 weeks prior to cycle 1 day 1;\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study
Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or steroids as computed tomography [CT] scan contrast premedication) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization; however,\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of =< 10 mg/day methylprednisolone equivalent) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 4 weeks prior to cycle 1, day 1; exceptions: (1) patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea); (2) the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) is allowed, provided the following is met: minimum of 2 weeks prior to cycle 1, day 1; patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled; the use of corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients receiving systemic treatment with any immunosuppressive medication (other than steroids as described above).
Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, other than dexamethasone for the underlying disease under investigation, as noted in the inclusion criteria;
Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
Use of immunosuppressive medication at the time of enrollment
Participants receiving systemic treatment with any immunosuppressive medication (other than steroids as described above)
Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of first dose of study drug
Has received systemic immunosuppressive treatments, aside from systemic corticosteroids within three months of start of study drug
Treatment with systemic immunosuppressive medications
Use of systemic corticosteroids or other systemic immunosuppressive drugs
Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Patients receiving systemic treatment with any immunosuppressive medication, excepting the above
Has received systemic immunosuppressive treatments, aside from systemic corticosteroids, within three months of start of study drug
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, premedication for a radiologic contrast allergy) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\r\n* Patients who receive low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed
Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs (e.g. cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to start of the study treatment (day 1 [D1] of cycle 1)
Any condition requiring concurrent systemic immunosuppressive therapy
Chronic immunosuppressive therapy
Chronic immunosuppressive therapy
Chronic treatment with corticosteroids or other immunosuppressive therapy
Chronic treatment with corticosteroids or other immunosuppressive agents
No addition or subtraction of other immunosuppressive medications for at least 4 weeks prior to starting treatment
On stable immunosuppressive regimen for 2 weeks prior to enrollment; adjustment of immunosuppressive medications to maintain a therapeutic level is permitted
New immunosuppressive medication or extracorporeal photochemotherapy (ECP) within 28 days of starting treatment with abatacept
Patients who have concurrent conditions resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
Chronic systemic therapy with immunosuppressive agents including corticosteroids.
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to first day of study treatment:
Ongoing immunosuppressive therapy.
Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1
Ongoing treatment with immunosuppressive drugs or dexamethasone > 4 mg
Systemic steroid or other immunosuppressive therapy within 4 weeks of starting the study
Ongoing treatment with steroid therapy or other immunosuppressive
Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), methotrexate, or other known immunosuppressive agents
Ongoing treatment with immunosuppressive drugs
Treatment with steroids or immunosuppressive therapy such as cyclosporine, tacrolimus, anti-thymocyte globulin (ATG) within 6 months of registration
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1, or anticipated requirement for systemic immunosuppressive medications during the trial\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the study chair\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) is allowed
Patients can continue to receive other immunosuppressive drugs for treatment of GVHD as determined by their primary team
Patients may not be on immunosuppressive therapy, including corticosteroids (with the exception of physiologic replacement, defined as 0.75 mg/m^2/day) at time of enrollment; however, patients who require intermittent use of bronchodilators or local steroid injections will not be excluded from the study
Patients who are taking immunosuppressive medication
Regular immunosuppressive therapy
Treatment with systemic immunosuppressive medications including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Cycle 1, Day 1. Participants who have received acute and/or low-dose systemic immunosuppressant medications may be enrolled in the study after discussion with and approval by the Medical Monitor. The use of inhaled corticosteroids and mineralocorticoids for participants with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial Cardiac Exclusion Criteria
Concomitant therapy with any of the following: interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
the subject has been off systemic immunosuppressive medications (including but not limited to: cyclosporine, tacrolimus, mycophenolate mofetil, or corticosteroids) for at least 1 month prior to the first dose of GSK525762. Topical steroids are permitted
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 1 week prior to cycle 1 day 1, or anticipated requirement for systemic immunosuppressive medications during the trial. Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone prior to the anthracycline-based chemotherapy for nausea) may be enrolled in the study. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
TREATMENT WITH SJCAR19: Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusion
Systemic therapy with immunosuppressive agents within 7 days before enrollment
Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:
Treatment with systemic immunosuppressive medication;
Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone continued for treatment of adrenal insufficiency is not considered a systemic IST
Ongoing immunosuppressive therapy other than corticosteroids.
Current or prior use of immunosuppressive medication within 28 days before the first study treatment
Receiving immunosuppressive therapy
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
MEDICATION-RELATED: Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1, Cycle 1 Exclusions Related to Other Medical Conditions or Medications
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Current or prior use of immunosuppressive medication within 7 days prior to study entry
Current or prior use of immunosuppressive medication within 14 days with some exceptions
Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study entry are ineligible
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomisation, or anticipated requirement for systemic immunosuppressive medications during the trial Exclusion Criteria Related to Capecitabine:
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study, with the following exceptions:\r\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\r\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\r\n* Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to start of study treatment.\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
A requirement for systemic immunosuppressive therapy for any reason
Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
Patients receiving concomitant immunosuppressive agents for medical condition
Must have been off immunosuppressive therapy for >= 7 days before receiving first dose of pembrolizumab
Significant active infection or immune deficiency (including chronic use of immunosuppressive drugs)
HEALTHY SUBJECT: Not taking regularly prescribed medication such as steroids, hormone therapy or immunosuppressive agents
History of allogenic organ transplantation that requires ongoing use of immunosuppressive agents is NOT permitted
No immunosuppressive medications except non-systemic corticosteroids
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to FATE-NK100 cell infusion (excluding preparative regimen premedications)
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to study treatment; but: a. patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled; b. the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility.
(Atezolizumab-Related Exclusion) Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1 a) Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. b) The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Chronically treated with systemic doses of immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1 day 1, or anticipated requirement for systemic immunosuppressive medications during the trial\r\n* Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone for adrenal insufficiency) is allowed
The following treatments must be discontinued:\r\n* Herbal medications\r\n* Immunomodulatory agents, including but not limited to interferons or IL-2\r\n* Immunosuppressive medications, including but not limited to cyclophosphamide, azathioprine, methotrexate, and thalidomide\r\n* Systemic corticosteroids\r\n* Anti?TNF-alpha agents
Current autoimmune disease requiring >= 20 mg/day of prednisone or systemic immunosuppressive therapy (eg. with cyclosporine or azathioprine).
Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of study registration
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to FATE-NK100 cell infusion (excluding preparative regimen pre-medications)
Currently taking immunosuppressive drugs within 28 days of study product injection (with exception of corticosteroids for tumor treatment)
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: subjects requiring therapy with immunosuppressive agents such as anti-tumor necrosis factor alpha (TNFa) agents (etanercept, adalimumab), azathioprine, methotrexate, cyclosporine, etc. for active autoimmune disorder.
Patients must not have a history of the following immunosuppressive conditions: bone marrow transplantation and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with a history of chronic lymphoid or leukemic malignancies which are not under active therapy (no active therapy within the last 3 months) will be eligible; patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months
Has a history of the following immunosuppressive conditions: bone marrow transplantation, and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with chronic lymphoid/leukemic malignancies that have undergone treatment in the last 3 months will be ineligible
Able to be off prednisone or other systemic immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications)
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NAM-NK cell infusion (excluding preparative regimen pre-medications)
Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017 administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL6, or anti-IL6R)
Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1
Patients with conditions requiring high doses of steroids or other immunosuppressive medications are excluded.
Has received systemic immunosuppressive treatments, aside from systemic corticosteroids (such as methotrexate, chloroquine, azathioprine, etc) within six months of registration
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Conditions requiring chronic steroid or immunosuppressive treatment that likely need additional steroid or immunosuppressive treatments in addition to the protocol therapy
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Subjects must be off of all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses of corticosteroids
No concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids.
Patient with previous administration of immunosuppressive therapy for SAA
Immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Patients who have a diagnosis of immunodeficiency (per PI discretion) or who have received treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents =< 14 days prior to study registration are not eligible\r\n* NOTE: patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., one-time dose of dexamethasone for nausea) may be enrolled in the study; the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed
Patients must not be receiving active immunosuppressive therapy.
Active immunosuppressive or cytotoxic therapy (excluding topical steroids) for any other condition.
Chronic treatment with corticosteroids or other immunosuppressive agents
Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses)
Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
Patients who have received prior immunotherapy whose side effects have resulted in a requirement of immunosuppressive medications (> 10 mg of prednisone daily or equivalent daily steroid daily, or infliximab, cyclosporine or equivalent immunosuppressive medication) or who have other autoimmune conditions that require immunosuppressive medications as above at the time of screening are excluded
Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment\r\n* Note: special considerations for vaccination: study-related treatments may be given after short-term steroid use (=< 4 days) with prior approval by the protocol chair and investigational new drug (IND) sponsor
Patients receiving systemic treatment with any immunosuppressive medication.
Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency
Patients on immunosuppressive agents
Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment.
Prior systemic use of any immunosuppressive chemotherapy (except low dose methotrexate) and/or monoclonal antibody treatment for CTCL
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents), or anticipated requirement for systemic immunosuppressive medications during the trial; patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone prior to the anthracycline-based chemotherapy for nausea) may be enrolled in the study; the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed
Have any active disease requiring systemic immunosuppressive treatment
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
Not currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporine
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Systemic steroid or immunosuppressive therapy within 14 days before vaccine administration
Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids
Autoimmune disorders on current immunosuppressive therapy
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to enrollment or anticipated requirement for systemic immunosuppressive medications during the trial\r\n* Patients who have received acute, low dose, systemic immunosuppressant medication (e.g., a one-time dose of dexamethasone for nausea) may be enrolled after a discussion and approval by the principal investigator\r\n* The use of inhaled corticosteroids and mineralocorticoids (eg, fludrocortisone) is allowed
Patients with active GVHD > grade 2 will be excluded; patients with recent increase in the immunosuppressive medication dose within last 2 weeks to control GVHD will not be included; patients with grade 1 or lower GVHD on =< 10 mg prednisone without any additional immunosuppressive therapies (tacrolimus, prograf, etc) will be eligible
Has received Hematopoietic Stem Cell Transplantation (HSCT) within 60 days of the first dose of DS-3032b, is on immunosuppressive therapy post-HSCT at the time of screening, or has clinically significant GVHD (use of topical steroids for ongoing skin GVHD will be permitted). Subjects must have a washout period of >=2 weeks or at least 4 half-lives from their last systemic immunosuppressive treatment for GVHD.
Concomitant therapy with any of the following: interleukin (IL)-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids while receiving ipilimumab (as long as steroid replacement is significantly greater than what is required for physiologic replacement, i.e. in hypothyroidism)
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids
Concomitant therapy with any of the following: interleukin (IL)-2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids in the previous 4 weeks
Patients who are receiving cyclosporine, tacrolimus, or other chronic immunosuppressive agents are NOT eligible for participation
Patients who have received any of the following concomitant therapy: interleukin (IL)-2, interferon or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) within 28 days prior to first dose
Administration of immunosuppressive drugs less than 2 weeks prior to first dose of ERC1671
Systemic or topical steroid use or other immunosuppressive therapy within the past 14 days
Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
The use of the following within 30 days before treatment:\r\n* Immunosuppressive drugs\r\n* Systemic glucocorticoids\r\n* Hematopoietic growth factors\r\n* Experimental therapy
Systemic immunosuppressive therapy in the past 14 days
Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses).
The use of the following within 14 days before treatment:\r\n* Chemotherapy\r\n* Radiation therapy\r\n* Immunosuppressive drugs\r\n* Systemic glucocorticoids\r\n* Hematopoietic growth factors\r\n* Experimental therapy
Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Concomitant therapy with any of the following: tamoxifen, toremifene, IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids greater than physiologic replacement doses; ocular steroid use is acceptable
Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A
Patients taking immunosuppressive drugs or who are unable to be temporarily removed from chronic anti-coagulation therapy.
Under active treatment with immunosuppressive agents such as systemic corticosteroids or cyclosporine that cannot be discontinued before starting rRp450 infusions
Patients who are taking immunosuppressive medication
Concurrent medical condition requiring the use of systemic immunosuppressive treatment within 28 days before the first dose of study treatment.
Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
Subject is receiving concomitant immunosuppressive therapy, defined as:\r\n* Immunosuppressants, including: tacrolimus, sirolimus, everolimus, cyclosporine, azathioprine, mycophenolate mofetil, antithymocyte globulin, basiliximab, belatacept\r\n* Systemic corticosteroids (except for short team treatment of allergic reactions or for treatment of immune related adverse events [irAE]); steroids with no or minimal systemic effect (topical, inhalation) are allowed\r\n* Chemotherapy\r\n* Immunotherapy\r\n* Monoclonal antibodies
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Patients must not be receiving active immunosuppressive therapy.
Active immunosuppressive therapy (excluding topical steroids) for any other condition.
GvHD requiring systemic immunosuppressive therapy
Ongoing systemic immunosuppressive therapy after haploidentical HCT
Current use of immunosuppressive medication at study entry, with the following exceptions:
207 Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Patient may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 562 at a low likelihood of relapse AND if there is agreement by both the investigator and the Amgen Medical Monitor.
Current use of immunosuppressive medication at the time of study enrollment.
Patients who have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti TNF] agents) within 2 weeks before initiation of study treatment\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids, and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or immunosuppressive medication including high-dose corticosteroids.
Have significant immunosuppression from concurrent, recent, or anticipated need for chronic treatment with systemic immunosuppressive dose of corticosteroids or immunosuppressive medications.
Active autoimmune disease requiring immunosuppressive treatment or history of autoimmune disease requiring immunosuppressive therapy (e.g. requirement for systemic therapy with >10 mg/day prednisone-equivalent) or any other concurrent use of immunosuppressive therapy.
received immunosuppressive therapy < 3 months prior to study Day 1
Concomitant therapy indicated with any of the following: interferons or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids
Subjects who have a known immunocompromised condition (HIV+, use of immunosuppressive medications or systemic steroids, organ transplant recipients)
Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1. (Patients who have received acute, low dose, systemic immunosuppressant medications [e.g., a one-time dose of dexamethasone for nausea] may be enrolled. The use of inhaled corticosteroids and mineralocorticoids [e.g., fludrocortisone] for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.)
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) =< 2 weeks prior to registration\r\n* Note:\r\n** Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n** The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Significant immunosuppression from concurrent, recent (=< 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy.
Need for ongoing treatment with an immunosuppressive agent
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to transplant (excluding preparative regimen premedications)
Autoimmune disorders on current immunosuppressive therapy
Is currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
Chronic treatment with corticosteroids or other immunosuppressive agents
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
Patients on chronic steroid use or other immunosuppressive agents
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients with active auto-immune disease requiring immunosuppressive medication
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Patients with a syndrome that requires administration of chronic systemic steroids or immunosuppressive agents; however, patients that require intermittent use of bronchodilators or local steroid injections are eligible
Patients who are taking immunosuppressive medications that cannot be discontinued (corticosteroids); patients who have discontinued immunosuppressive medications but be at least 1 week post their last dose
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents including but not limited to methotrexate, chloroquine, azathioprine, etc. within six months of study participation
Able to be off prednisone or other immunosuppressive medications other than that prescribed per protocol for at least 3 days prior to day 0
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents; chronic use of systemic corticosteroids
Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., limited low-dose dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study and would not require a 7 day washout
Active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)
Patients who have received any of the following concomitant therapy: interleukin (IL)-2, interferon; immunosuppressive agents; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses)
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications)
Has a diagnosis of immunosuppressive disorder OR is on any other form of immunosuppressive therapy within 7 days prior to transplant admission
Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Any heart or lung transplant patient on immunosuppressive agents; renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis; patients with chronic lymphocytic leukemia (CLL) or other hematologic malignancies are allowed
Patients who require systemic corticosteroid or other immunosuppressive therapy; immunosuppressive therapy must be stopped at least 14 days prior to cell infusion
Concurrent therapy with systemic corticosteroids or other immunosuppressive medications
Patients must not be currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
A requirement for systemic immunosuppressive therapy for any reason
Patients needing chronic, immunosuppressive systemic steroids are excluded
Immunosuppressive medications including systemic corticosteroids unless used for adrenal replacement, appetite stimulation, acute therapy for asthma or bronchitis exacerbation (=< 2 weeks), or antiemesis
Patients needing chronic, immunosuppressive systemic steroids are excluded
Patients with autoimmune diseases that require immunosuppressive medications are excluded
Use of systemic corticosteroids or other immunosuppressive agents within the previous 4 weeks of study enrollment
No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment
Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
Concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
Systemic immunosuppressive therapy for any reason
Immunosuppressive regimens involving systemic corticosteroids within 14 days before the first dose of study treatment.
Current or prior use of immunosuppressive medication within 14 days with some exceptions.
Treatment with systemic immunosuppressive medications within 2 weeks prior to first dosing (inhaled corticosteroids and mineralocorticoids are allowed).
Immunosuppression: Any immunosuppressive medication must be stopped ? 4 weeks prior to enrollment
Expected need for regular immunosuppressive therapy
Active systemic immunosuppressive therapy
Concurrent or prior use of immunosuppressive medication with 14 days
Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
Ongoing immunosuppressive therapy
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:
Ongoing systemic immunosuppressive therapy other than corticosteroids.
Patients on immunosuppressive therapy including systemic corticosteroids.
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) at the time of initiation of study drug, or anticipated requirement for systemic immunosuppressive medications during the study
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or conditions such as common variable hypogammaglobulinemia
Treatment with systemic immunosuppressive medications, including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents within 2 weeks prior to Cycle 1, Day 1; inhaled corticosteroids and mineralocorticoids are allowed
No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks prior to randomization
Use of immune modulators and/or any immunosuppressive drugs.
Treatment with systemic immunosuppressive medications
No disease requiring systemic immunosuppressive therapy
Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
Receiving immunosuppressive therapy
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-· agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions: patients who received low-dose immunosuppressant medication are eligible for the study; patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment
Concomitant therapy with any of the following: interleukin 2 (IL-2), interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses)
Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days.
Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
Immunosuppressive therapy
Use of systemic immunosuppressive drugs
Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ? 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent.
Use of corticosteroids or other immunosuppressive medications
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1 \r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids or mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients receiving systemic treatment with any immunosuppressive medication.
Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level ? 10 mg/day within 7 days of initiating study treatment.
Patients receiving systemic treatment with systemic steroid therapy or any other immunosuppressive medication at any dose level that would interfere with the action of the study drugs in the opinion of the investigator
Systemic immunosuppressive medication within 2 weeks prior to study drug
Systemic treatment with corticosteriods or other immunosuppressive medications within 14 days of study drug administration
Current or prior use of immunosuppressive medication within 28 days before start of treatment.
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) =< 14 days prior to randomization; exception: patients who have received acute, low-dose, systemic immunosuppressant medications (e.g. a one-time dose of dexamethasone for nausea) are eligible; the use of inhaled corticosteroids and mineral-corticoids (e.g. fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Current immunosuppression or taking immunosuppressive drugs
Treatment with systemic immunosuppressive medications, including but not limited to prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to D1C1
Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline
Current or prior use of immunosuppressive medication within 14 days of first dose
Patients on immunosuppressive therapy including:
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1 \r\n*Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n*The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy not related to chemotherapy administration.
Use of corticosteroids or other immunosuppressive medications
Patients taking immunosuppressive medications
Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of first dose of study drug
No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment; the dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Post-transplant exposure to any novel immunosuppressive medication (e.g., alemtuzumab) within 100 days prior to enrollment
Has received systemic immunosuppressive treatments, aside from systemic corticosteroids as described below (such as methotrexate, chloroquine, azathioprine, etc) within six months of start of study drug
Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;
No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment; the dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI6383. )
Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736
Any condition requiring concurrent systemic immunosuppressive therapy
Immunosuppressive therapy (excluding topical steroids) for any other condition =< 4 weeks prior to registration
Immunosuppressive disease
Severely immunocompromised patients (eg transplant, on immunosuppressive drugs)
COHORT A: Concomitant or prior therapy with any of the following: aldesleukin (IL-2), interferon, or other non-study immunotherapy regimens; immunosuppressive agents; or chronic use of systemic corticosteroids within 6 weeks of study entry
COHORT B: Concomitant or prior therapy with any of the following: IL-2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; or chronic use of systemic corticosteroids within 6 weeks of study entry
Any condition requiring active steroid or other immunosuppressive therapy
Prior treatment with clusters of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, systemic immunostimulatory agents, or systemic immunosuppressive medications
Chronic immunosuppressive therapies, including systemic corticosteroids
Patients who have received any of the following concomitant therapy: interleukin (IL)-2, interferon or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) within 1 week prior to first dose; Note: systemic steroid therapy allowed for subjects with primary brain tumors as long as =< dexamethasone 4 mg or its steroid equivalent
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n*Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n*The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Concomitant use of the following medications\r\n* Any investigational anticancer therapy\r\n* Any concurrent chemotherapy, immunotherapy, or biologic therapy; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable\r\n* Immunosuppressive medications including, but not limited to systemic corticosteroids (> 10 mg/day prednisone or equivalent), methotrexate, azathioprine, and tumor necrosis factor alpha (TNF-alpha) blockers; use of immunosuppressive medications for the management of investigational product-related adverse event (AE)s, in subjects with contrast allergies is acceptable; in addition, use of inhaled and intranasal corticosteroids is permitted
Current use of immunosuppressive medication at the time of study enrollment.
No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
A requirement for chronic systemic immunosuppressive therapy for any reason
Concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
Prior chronic immune suppressive state (acquired immune deficiency syndrome [AIDS], immunosuppressive therapy)
Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring dexamethasone for treatment of tumor-related edema
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
Concomitant therapy with any of the following: interleukin (IL) 2 or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; unless discontinued >= 4 weeks; a history of occasional use of steroid inhalers is allowed
Concomitant therapy with any of the following: interleukin (IL)2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
Immunosuppressive agents (unless required for treating potential AEs)
Receiving ongoing treatment with immunosuppressive drugs, excluding those patients requiring dexamethasone for treatment of tumor-related edema
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications)
Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (except for those prescribed as part of the study)
Patients requiring chronic immunosuppressive therapy (including corticosteroids) for any medical condition
Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
Chronic treatment with systemic steroids or another immunosuppressive agent
History of liver transplant requiring increased immunosuppressive therapy. (Participants on maintenance immunosuppressive therapy after liver transplant are eligible for Part A & B)
Require concurrent treatment with immunosuppressive agents (other than corticosteroids prescribed for a short course of therapy)
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1 \r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients on immunosuppressive drugs (with exception of corticosteroid)
Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
Ongoing systemic immunosuppressive therapy other than corticosteroids
Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
Is on chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
Ongoing immunosuppressive therapy other than corticosteroids
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1
Active treatment with corticosteroids or other immunosuppressive agents
Subjects with any condition requiring systemic corticosteroids, cytotoxic therapy or immunosuppressive medications
Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
Chronic treatment with steroids or other immunosuppressive agents for medical conditions other than cancer. Patients who require steroids for treatment of tumor-associated cerebral edema are eligible.
Ongoing immunosuppressive therapy other than corticosteroids
use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of SG2000.
Patients who require systemic corticosteroid or other systemic immunosuppressive therapy; immunosuppressive therapy must be stopped at least 28 days prior to enrollment; topical agents and/or inhaled corticosteroids are permitted
Patient requires chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine)
Patients must not require chronic use of immunosuppressive agents (e.g. methotrexate, cyclosporine)
Receiving immunosuppressive drugs
Treatment with systemic immunosuppressive medications within 2 weeks prior to the first dose of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Patients requiring continuous, systemic immunosuppressive therapy
Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Chronic treatment with systemic steroids or another immunosuppressive agent
Concurrent or prior use of immunosuppressive medication within 28 days;
Need for ongoing treatment with an immunosuppressive agent.
Concomitant therapy with any of the following: interleukin (IL)2 or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; unless discontinued >= 4 weeks; a history of occasional use of steroid inhalers is allowed
Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
Subjects taking immunosuppressive medications at the screening visit
Participant has not taken immunosuppressive medications for at least 2 weeks
Concurrent or prior use of immunosuppressive medication within 14 days
Patients receiving steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or chronic medical conditions, and intermittent dexamethasone as antiemetics are allowed).
Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
Clinically uncontrolled autoimmune disorders, transplant recipients who depend on immunosuppressive therapy, other immunosuppressive conditions including any concurrent condition requiring immunosuppressive/immunomodulating agents;
Use of any systemic immunosuppressive agents
Systemic steroid or other immunosuppressive therapy within 4 weeks of starting the study
Systemic immunosuppressive agents (including corticosteroids) have not been received for at least 8 weeks
Any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection
No active (as defined by requiring immunosuppressive therapy) or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy)
On immunosuppressive therapy.
Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Receiving immunosuppressive therapy
Patient is currently receiving increasing or chronic treatment with corticosteroids or another immunosuppressive agent
Immunosuppressive medications or immunosuppressive doses of systemic corticosteroids
Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
Concomitant therapy with any of the following: aldesleukin (IL-2), interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Chronic treatment with systemic steroids or another immunosuppressive agent
Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617
Immunosuppressive therapy within the last 3 months
The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Systemic steroid (except inhaled steroids) or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment
Patients on immunosuppressive drugs (with exception of corticosteroid)
Patients who are currently taking immunosuppressive medications
Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment
History or evidence of active autoimmune disease, requiring systemic steroid therapy within 28 days of study screening or other systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) or anticipated requirement for systemic immunosuppressive medications during the trial\r\n* Patients on inhaled or topical steroids are eligible\r\n* Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the principal investigator\r\n* Replacement therapy (e.g., thyroxin, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)) within 2 weeks prior to Cycle 1, Day 1
Subjects on concurrent anticoagulant, or immunosuppressive medication
Subjects on concurrent anticoagulant, or immunosuppressive medication
Patients receiving chronic treatment with oral steroids or another immunosuppressive agent (excluding steroids as part of the chemotherapy pre-medication or emetic medication)
immunodeficiency, immune compromised state or receiving immunosuppressive therapy
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
Treatment with systemic immunosuppressive medications including but not limited to: prednisone, dexamethasone, cyclosporin, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor (TNF) agents , hydroxychloroquine within 2 weeks of first study dose\r\n* Patients who have received acute, low-dose systemic immunosuppressant medications may be enrolled\r\n* Patients with adrenal insufficiency on physiologic replacement doses of steroids may be enrolled\r\n* The use of inhaled, topical intraocular, or intraarticular corticosteroids or mineralocorticoids are allowed
Current use of cytotoxic or immunosuppressive drugs
Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
Patients taking immunosuppressive medications (other than dexamethasone) will be excluded
Participants must be receiving systemic glucocorticoid therapy for cGVHD; all immunosuppressive therapy may include but not be limited to tacrolimus, sirolimus, CellCept, cyclosporine, and systemic corticosteroid must be at stable doses for 28 days prior to the first cell infusion
Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ? 5 mg daily.
Treatment with systemic corticosteroids or other immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
No addition or subtraction of other immunosuppressive medications (e.g., calcineurin inhibitors, sirolimus, mycophenolate mofetil) for 2 weeks prior to enrollment; the dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment; the dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
Patients on chronic immunosuppressive medications, including steroids, within the past three months
Participants may not have received > 1 systemic immunosuppressive agent beyond corticosteroids for the treatment of GVHD; GVHD prophylaxis regimens used for an individual patient do not count as additional agents
Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
Patients regularly use steroid or other immunosuppressive medications
No addition or subtraction of other immunosuppressive medications (e.g., calcineurin inhibitors, sirolimus, mycophenolate mofetil) for 4 weeks prior to enrollment; the dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Active cGVHD despite treatment with at least two immunosuppressive treatments (not including GVHD prophylaxis) in the past year
Subject has not started any new systemic immunosuppressive therapies within 2 weeks prior to enrollment
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
RECIPIENT: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
Need for chronic immunosuppressive drugs
Need for chronic immunosuppressive drugs
Patients with steroid refractory chronic GVHD must be on stable doses of corticosteroids and other immunosuppressive medications for 2 weeks prior to enrollment
Patients with steroid refractory cGVHD cannot have prior exposure to any new immunosuppressive medication in the preceding 2 weeks prior to enrollment
Patients who take immunosuppressive medication, i.e. steroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injection
Is taking immunosuppressive therapy
Other risk factors for the development of osteonecrosis of the jaw (ONJ) including poor oral hygiene, use of a dental appliance, immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, or gingival infections
Chronic immunosuppressive therapy within 30 days of screening
Patients who have chronic immunosuppression or are on current immunosuppressive therapies
Treatment with systemic immunosuppressive medications within 2 weeks prior to first day of study treatment (inhaled corticosteroids and mineralocorticoids allowed)
Confirmed or suspected immunosuppressive or immunodeficient condition
Subjects taking immunosuppressive medications at the screening visit (day 0)
Treatment with systemic immunosuppressive medication
Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
Are immunosuppressed or in chronic use of immunosuppressive drugs.
Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
Subjects on chronic steroid therapy, other immunosuppressive therapy
Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency
Treatment with systemic corticosteroids or other systemic immunosuppressant medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti?tumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1, or anticipated requirement for systemic immunosuppressive medications during the trial; patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study; patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using magnetic resonance imaging (MRI); the use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed
Is on chronic systemic steroid therapy in excess of replacement doses or on any other form of immunosuppressive medication.
ongoing chronic immunosuppressive therapy
Has a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study
currently or previously required systemic immunosuppressive or immunomodulatory therapy (including corticosteroids administered by systemic route) and/or
Systemic treatment with steroids or other immunosuppressive agents within 30 days prior to entry. Physiological replacement with hydrocortisone or equivalent is acceptable.