A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria * ≥ 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 Exclusion Criteria * Any known allergies to the components or excipients of the C-CAR088 cell product * Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis * Central nervous system (CNS) involvement * Stroke or convulsion history within 6 months prior to signing informed con