A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma
This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.
• ≥ 18 years of age, male or female patients
• Relapsed or refractory multiple myeloma
• Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
• Had measurable disease as defined by any of the following criteria:
‣ Serum M protein ≥ 0.5g/dL
⁃ Urine M protein ≥ 200mg/24h
⁃ Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
• Adequate liver, renal, bone marrow, and heart function
• Eastern cooperative oncology group (ECOG) 0-1