A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Biological: B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
- Registration Number
- NCT05521802
- Lead Sponsor
- Shanghai AbelZeta Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C-CAR088 B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell Autologous C-CAR088 administered by intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method [phase Ib] Incidence and severity of Adverse Events 24 months Incidence and severity of Adverse Events
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion 3 months the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
- Secondary Outcome Measures
Name Time Method Minimal residual disease (MRD) negativity rate 24 months The rate of patients reached MRD negativity
Maximal plasma concentration (Cmax) 24 months maximal plasma concentration of C-CAR088 in peripheral blood
Time to response (TTR) 24 months The time from the date of C-CAR088 infusion to the first documented PR or better
Overall survival (OS) 24 months The time from the date of C-CAR088 infusion to the date of death
Overall response rate (ORR) 24 months The rate of patients with best response of partial response (PR) or better
Progression-free survival (PFS) 24 months The time from the date of C-CAR088 infusion to the date of first documented disease progression or death
Time to reach the maximal plasma concentration (Tmax) 24 months Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood
Anti-drug (C-CAR088) antibody 24 months Presence of serum anti-drug (C-CAR088) antibody
Serum free light chain (sFLC) 24 months Serum free light chain (sFLC) concentration changes over time
[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion 3 months The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Duration of response (DOR) 24 months The time from the first documented PR or better response to relapse or death, whichever occurs first
[phase II] Incidence and severity of Adverse Events 24 months Incidence and severity of Adverse Events
Time of last measurable observed concentration (Tlast) 24 months Time of last measurable observed concentration of C-CAR088 in peripheral blood
Area under the curve within 28 days (AUC0-28d) 28 days Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion
Serum M protein 24 months serum M proteins concentration changes over time
Urine M protein 24 months Urine M proteins concentration changes over time
Trial Locations
- Locations (1)
Institute of Hematology and Blood Diseases Hospital
🇨🇳Tianjin, China