Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase II
Principal Investigator: Alsina, Melissa
A Phase 2, Multi-Cohort, Open-Label, Multicenter Study To Determine The Efficacy And Safety Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma And In Subjects With High-Risk Multiple Myeloma Having Progressed Within One Year Of Initial Treatment
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within one 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), and without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c) Approximately 181 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with > 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently.
Primary Objective: The primary objective of the study is to evaluate the preliminary efficacy of bb2121 in subjects with RRMM and in subjects with HR MM having progressed within one year of initial treatment Secondary Objective: Evaluate the safety of bb2121 in subjects with RRMM and in subjects with HR MM having progressed within one year of initial treatment Evaluate additional efficacy parameters of bb2121 Characterize the expansion and persistence of chimeric antigen receptor (CAR) + T cells, in the peripheral blood and bone marrow (by vector copy number [VCN]) Evaluate the development of an anti-CAR antibody response Evaluate the percentage of subjects who attain minimal residual disease (MRD) negative status (by EuroFlow and next generation sequencing [NGS]) Evaluate changes in health-related quality of life (HRQoL)
Chemotherapy (NOS); Immunotherapy
bb2121 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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