Clinical Trials Search
A Phase 1 Study of bb21217, an anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma
Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM). The purpose of this study is to evaluate if gene transfer therapy is a safe and tolerable way to treat the participant's multiple myeloma. The study will also evaluate how well the investigational T cells kill the their tumor cells.
The primary objectives of the study are: -Determine the maximally tolerated dose (MTD) and a recommended phase 2 dose (RP2D) of bb21217 in subjects with relapsed or refractory multiple myeloma (MM) for future studies. -Confirm the safety of the RP2D. The secondary objective of the study is to: -Provide preliminary efficacy data on the anti-tumor effects of treatment with bb21217 in subjects with MM. The exploratory objectives of the study are to: -Evaluate the overall survival and progression-free survival of subjects treated with bb21217. -Evaluate the persistence, immune phenotype, and function of bb21217 in the blood, bone marrow, and/or tumor tissue. -Evaluate cytokine/chemokine induction in the blood of subjects after infusion of bb21217. -Evaluate the level of BCMA+ cells in blood and bone marrow, and the level of circulating soluble BCMA. -Evaluate measures of tumor sensitivity/resistence to bb21217. -Evaluate minimal residual disease (MRD). -Evaluate the development of an anti-CAR immune response by assessment of anti-CAR antibodies. -Evaluate the utility of the immunohistochemistry (IHC) BCMA expression assay.
Not Applicable (); bb21217 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)