This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JCARH125 administered intravenously (IV).
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Key Inclusion Criteria:
Diagnosis of multiple myeloma (MM) with relapsed or refractory disease after at least 3 prior lines of therapy that are considered standard of care. Prior lines of therapy include:
Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible. For subjects who exhibited duration of response > 12 months to immediate prior line of therapy, administration of an additional line of available therapy in lieu of JCARH125 should be considered.
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
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