Multiple Myeloma Clinical Trial
Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
ARM 1 is a non-randomized, open label, multi-site Phase 1 study. CART-ddBCMA is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.
ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)
Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
Documented measurable disease
Adequate organ function
Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1
Plasma Cell Leukemia or History of Plasma Cell Leukemia
Patients with a history of severe hypersensitivity to DMSO should be excluded
Contraindication to fludarabine or cyclophosphamide
Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
Active central nervous system disease involvement by malignancy or active CNS pathology
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There are 4 Locations for this study
Chicago Illinois, 60637, United States
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