Subject has received or plans to receive the following excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy. Required Wash-out periods:
Study subjects < 18 years of age who cannot undergo the leukapheresis procedure, do not meet the disease staging and/or the size criteria for frequent blood donations
No prior anti-leukemic therapy except the following are allowed: < 1 week of corticosteroids, or hydroxyurea or emergent leukapheresis; longer steroid use for diseases other than leukemia is permitted
DONOR: Deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
Use of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide ? 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped ? 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis\r\n* Daratumumab or any other anti-CD38 monoclonal antibody therapy within 30 days of leukapheresis
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Use of any of the following:\r\n* Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis; physiologic replacement, topical, and inhaled steroids are permitted\r\n* Allogeneic hematopoietic stem cell transplant (allo-HSCT) within 90 days of leukapheresis\r\n* Cytotoxic chemotherapeutic agents within 1 week of leukapheresis; oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis\r\n* Low dose chemotherapy (e.g., bortezomib, lenalidomide, cyclophosphamide =< 300 mg/m^2) given after leukapheresis to maintain disease control must be stopped >= 7 days prior to initiation of lymphodepleting chemotherapy\r\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis\r\n* Experimental agents within 4 weeks of leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis
CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION
Screening evaluation appropriate for leukapheresis and T-cell collection
CRITERIA FOR SCREENING: Any known contraindication to leukapheresis
CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: Use of any of the following:\r\n* Cytotoxic or lymphotoxic agents (including prednisone > 5 mg/day or equivalent corticosteroid) within 1 week prior to leukapheresis; physiologic corticosteroid replacement, and topical or inhaled corticosteroids are not excluded\r\n* GVHD therapies within 4 weeks prior to leukapheresis (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6R)\r\n* Experimental agents within 4 weeks prior to leukapheresis unless progression is documented on therapy and at least 3 half-lives have elapsed prior to leukapheresis\r\n* Radiation within 6 weeks prior to leukapheresis unless there is progressive disease in irradiated lesions or there are additional non-irradiated, positron emission tomography (PET)-positive lesions \r\n* Allo-HSCT within 60 days prior to leukapheresis or donor lymphocyte infusion (DLI) within 6 weeks prior to leukapheresis\r\n* Treatment with cladribine within 3 months prior to leukapheresis\r\n* Treatment with alemtuzumab within 3 months prior to leukapheresis
Adequate vascular access for leukapheresis procedure
Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or cladribine within 3 months of leukapheresis
Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis.
Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosofamide, bendamustine) within 2 weeks of leukapheresis.
Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
Any condition contraindicating leukapheresis.
Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood obtained by phlebotomy and/or consent to leukapheresis for DC generation.
Known exclusion criteria for leukapheresis, JCAR014, or durvalumab therapy
EXCLUSION CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION:
INCLUSION CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION:
Screening evaluation appropriate for leukapheresis and T-cell collection
INCLUSION CRITERIA FOR TNBC: Patients must be off chemotherapy for a minimum of 3 weeks prior to planned leukapheresis
DONOR: Cardiac risk factors precluding ability to undergo leukapheresis
No contraindications for leukapheresis
No contraindications for leukapheresis
Patients must be willing to undergo two leukapheresis procedures for the investigational component of this trial
Patient may be required to undergo leukapheresis (depending on the study phase/cohort) and must agree to leukapheresis if so assigned
DONOR: Capable of undergoing leukapheresis
Research participants' last dose of prior chemotherapy or radiation must be >= 2 weeks before leukapheresis; Note: this criterion is not applicable if the research participant's donor is undergoing leukapheresis
The last dose of prior chemotherapy, immunotherapy or radiation must be at least 2 weeks before the leukapheresis procedure
The last dose of cytotoxic chemotherapeutic agents that are not considered lymphotoxic must be at least one week before the leukapheresis procedure; oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis
The last dose of lymphotoxic chemotherapeutic agents (e.g. cyclophosphamide, ifosofamide, bendamustine, etc) must be at least 2 weeks before the leukapheresis procedure
The last dose of investigational agents must be at least 2 weeks before leukapheresis procedure unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives must have elapsed prior to leukapheresis
If research participant is undergoing leukapheresis, he/she must be at least 2 weeks from having received the last dose of immunosuppressant medications\r\n* Exceptions:\r\n** Steroids and tyrosine kinase inhibitors are allowed up to 7 days prior to leukapheresis\r\n** Research participant cannot be on more than 5 mg prednisone or equivalent doses of other corticosteroids at the time of leukapheresis
If research participant is undergoing leukapheresis the last dose of prior chemotherapy, immunotherapy or radiation must be at least 2 weeks before the leukapheresis procedure\r\n* Exception rule: the wash out period for Hydrea is 48 hours
ELIGIBILITY TO UNDERGO LYMPHODEPLETION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
No contraindications for leukapheresis
DONOR: Related donors < 18 years of age requiring placement of a leukapheresis catheter will donate peripheral blood collected by phlebotomy (including a unit of blood if weight permits) and shall not undergo catheter placement for leukapheresis
Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood obtained by phlebotomy and/or consent to leukapheresis for DC generation.
Availability of production capacities for the patient's IMA202 product prior to the leukapheresis TREATMENT SCREENING:
Any condition contraindicating leukapheresis
Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred.
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
DONOR: Able and willing to undergo leukapheresis
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
DONOR: Individuals deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
Medical or psychiatric reasons which make the donor unlikely to tolerate or cooperate with filgrastim (G-CSF) therapy or leukapheresis or bone marrow harvest
Subject who has had cytotoxic chemotherapy within 3 weeks prior to leukapheresis; immune therapy or biological therapy within 4 weeks prior to leukapheresis; corticosteroids or any other immunosuppressive therapy within 2 weeks prior to leukapheresis; tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) and any other anti-cancer treatment within 1 week prior to leukapheresis.
Investigational treatment within 4 weeks prior to leukapheresis; experimental anti-cancer vaccine within 2 months prior to leukapheresis in the absence of response or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months prior to leukapheresis; any prior gene therapy using an integrating vector.
Unwilling to undergo two leukapheresis procedures; if patients are unable to undergo the leukapheresis procedures, then a 200-cc blood draw (green heparinized tubes) is permitted in place of the leukapheresis
Patients with medical conditions precluding leukapheresis
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Use of any of the following medications or treatments within the noted time prior to leukapheresis:
Alemtuzumab within 6 months prior to leukapheresis
Cladribine within 3 months prior to leukapheresis
Fludarabine within 4 weeks prior to leukapheresis
Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
Venetoclax within 4 days prior to leukapheresis
Lenalidomide within 1 day prior to leukapheresis
Experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
Having received systemic immune suppressive therapy within 30 days prior to leukapheresis
No contraindications for leukapheresis
Patients may receive hydroxyurea, steroids, or leukapheresis as necessary until day 5 of treatment
Adequate central or peripheral vascular access for leukapheresis procedure
Steroids: Therapeutic doses of corticosteroids are prohibited within 7 days prior to leukapheresis.
Chemotherapies: Salvage chemotherapy must be stopped at least 1 week prior to leukapheresis
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
Donor must be able to undergo leukapheresis
Donor has cardiac risk factors precluding ability to undergo leukapheresis
DONOR: Able and willing to undergo leukapheresis
CRITERIA FOR LEUKAPHERESIS:
Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); (if a patient was not tested at the time of their leukapheresis, they must be tested prior to receiving T cell infusion; if testing was done for leukapheresis, this is adequate and does not need to be repeated)
Patients may receive hydroxyurea, steroids, or leukapheresis as necessary until day 5 of treatment
DONOR: Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Leukapheresis;
Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
Cytotoxic chemotherapeutic agents that are not considered lymphotoxic within 1 week of leukapheresis. Oral chemotherapeutic agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis.
Lymphotoxic chemotherapeutic agents (eg, cyclophosphamide, ifosfamide, bendamustine) within 2 weeks of leukapheresis.
Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis.
GVHD therapies within 4 weeks of leukapheresis and JCAR017 administration.
Radiation within 6 weeks of leukapheresis.
Inability to undergo leukapheresis
Patients may receive anagrelide for up to 28 days (in countries where the product is registered). Leukapheresis is allowed up to 24 hours prior to the first treatment cycle with omacetaxine.
Leukapheresis ? 2 weeks prior to starting CC-90009.