Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
Master protocol for cell therapy, Phase 1 proof-of-concept studies., in relapsed and
 refractory multiple myeloma and includes long-term safety follow-up.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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