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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Shanghai AbelZeta Ltd.
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- [phase Ib] Incidence and severity of Adverse Events
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Detailed Description
The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
[phase Ib] Incidence and severity of Adverse Events
Time Frame: 24 months
Incidence and severity of Adverse Events
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion
Time Frame: 3 months
the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Secondary Outcomes
- Minimal residual disease (MRD) negativity rate(24 months)
- Maximal plasma concentration (Cmax)(24 months)
- Overall response rate (ORR)(24 months)
- Serum free light chain (sFLC)(24 months)
- Time to response (TTR)(24 months)
- Overall survival (OS)(24 months)
- Progression-free survival (PFS)(24 months)
- Time to reach the maximal plasma concentration (Tmax)(24 months)
- Anti-drug (C-CAR088) antibody(24 months)
- [phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion(3 months)
- Duration of response (DOR)(24 months)
- [phase II] Incidence and severity of Adverse Events(24 months)
- Time of last measurable observed concentration (Tlast)(24 months)
- Area under the curve within 28 days (AUC0-28d)(28 days)
- Serum M protein(24 months)
- Urine M protein(24 months)