This is an open-label, single-arm, non-randomized multicenter Phase 2 study evaluating RAPA-201 cells in subjects with relapsed, refractory multiple myeloma. After a subject consents to the study, an apheresis procedure will be performed to collect cells to manufacture the investigational product, RAPA-201 cells. During Cycle 1, subjects will receive pentostatin and low-dose, dose-adjusted Cyclophosphamide (PC regimen), but will not receive RAPA-201 cells. During Cycles 2 and beyond, Subjects will receive a conditioning regimen consisting of the PC regimen followed by the RAPA-201 cell infusions. Subjects will receive at minimum five cycles of treatment. If a subject has stable disease, they will receive an additional four cycles of PC regimen+RAPA-201 cells. All subjects who complete the active treatment portion of the study, prematurely terminate the study, or subjects who discontinue active treatment due to a toxicity attributable or related to the study drug will complete the follow-up portion of the study (approximately one year). Patients who experience progressive disease will be taken off study.
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.
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