Cancer Type: Multiple Myeloma
Study Type: Treatment
Phase: Phase II
Principal Investigator: Freeman, Ciara
A Phase II Study of CART-ddBCMA for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
A Phase II study of CART-ddBCMA for patients with relapsed or refractory multiple myeloma. CART-ddBCMA is a BCMA-directed CAR-T cell therapy
Primary The primary objective of this study is to determine the efficacy, as assessed by ORR, of CARTddBCMA in subjects with relapsed or refractory multiple myeloma (RRMM). Secondary -To further characterize the safety of CART-ddBCMA in subjects with RRMM -To determine the efficacy, as assessed by ORR, of CART-ddBCMA in subjects with relapsed or refractory multiple myeloma (RRMM) limited to three lines of prior treatment -To describe depth (i.e., rate of CR/sCR, VGPR, PR) and duration of responses (DoR), progression free survival (PFS), Time to Progression (TTP), and Overall Survival (OS) -To characterize the cell expansion kinetics of CART-ddBCMA in terms of peak quantification in peripheral blood, timing of peak expansion, relationship of peak expansion timing and quantification to efficacy and toxicity as assessed by vector copy number (VCN) -To characterize cell persistence of CART-ddBCMA and relationship to efficacy as assessed by vector copy number (VCN) measurability at each timepoint -To characterize the anti-CART-ddBCMA antibody response in subjects with RRMM -To characterize the impact of CART-ddBCMA in subjects with RRMM on healthrelated quality of life (HRQoL) using the EQ-5D-5L, EORTC-QLQ-C30, and EORTCQLQ- My20 quality of life assessments. Exploratory -To characterize the impact of baseline tumor burden in patients with RRMM on efficacy, safety, and cell expansion -To characterize the frequency with which minimal residual disease (MRD) becomes undetectable (i.e., MRD-negative) in subjects with RRMM after treatment with CARTddBCMA and assess the relationship of MRD-negativity to ORR, CR/sCR rate, DoR, PFS, TTP, and OS -To characterize serum cytokine levels during the screening and treatment periods and any relationship to efficacy and/or safety -To characterize the phenotype of CART-ddBCMA cells in the peripheral blood and bone marrow, when possible, using flow cytometry -To characterize the quantity of soluble BCMA (sBCMA) in subjects with RRMM treated with CART-ddBCMA and the relationship of sBCMA to efficacy and safety -To characterize drug product attributes and their relationship to efficacy and/or safety -To determine and understand the manufacturing outcomes and drug product related attributes -To measure healthcare resource utilization
Cell Therapy; Chemotherapy (NOS)
CART-ddBCMA (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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