Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells. |
| Who can participate | Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled: * Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures; * 18 to 75 years old (including cut-off value)，gender is not limited; * Expected survival \> 12 weeks; * Previously diagnosed as multiple myeloma by the International Myeloma Working Group（IMWG） updated criteria; * One of the following indicators is satisfied: 1. Serum M protein ≥ 5 g/L; 2. Urine M protein ≥ 200 mg/24h; 3. Affected serum free light chain ≥ 100 mg/L and Serum free light chain ratio is abnormal ; * Patients with relapsed/refractory multiple myeloma, satisfying: 1. Patients have received at least 3 prior MM treatment regimens |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Hrain Biotechnology Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China; Wenzhou, Zhejiang, China |
| Start date | 2022-07-12 |
| NCT ID | NCT05594797 |
| Official listing | https://clinicaltrials.gov/study/NCT05594797 |