Cancer Type: Multiple Myeloma
Study Type: Treatment
NCT#: NCT03915184
Phase: Phase I
Principal Investigator: Castaneda Puglianini, Omar
Open Label, Multi-Center, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma
This is an open label, multi-center, phase 1b clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; CT053) in patients with relapsed and or refractory multiple myeloma.
Primary: -Evaluate the safety and tolerability of CAR-BCMA T cell (CT053) therapy in patients with rrMM -Identify the MTD and explore a RP2D of CT053 therapy in patients with rrMM Secondary: -Evaluate clinical efficacy outcomes with CAR-BCMA T cell (CT053) therapy in patients with rrMM Exploratory: -Evaluate Health-related Quality-of-Life (HRQoL) therapy in patients with rrMM from baseline up to study completion -Evaluate CT053 cell's pharmacokinetics (PK) and biodistribution
Cell Therapy; Chemotherapy (NOS)
CT053 (); Not Applicable (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Inclusion Criteria:
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