drugset / Trial / NCT07234721
SL4903 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
Phase 0
Not yet recruiting
9 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Hebei Senlang Biotechnology Inc., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I, single-center, single-arm, open-label clinical study to evaluate the safety, tolerability, and preliminary efficacy of SL4903 autologous T-cell injection (CAR-T cell therapy) in adult patients with relapsed or refractory multiple myeloma (r/r MM) who have failed prior standard therapies. The study employs a "3+3" dose-escalation design with three planned dose levels (1×10⁶, 2×10⁶, and 3×10⁶ CAR+ cells/kg). Approximately 9 to 18 evaluable subjects will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), and to characterize the safety profile and potential anti-myeloma activity of SL4903.
Timeline
- Start
- 2026-02-01
- Primary completion
- 2028-03-20
- Completion
- 2028-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SL4903 | Cell therapy | 1e+06 cells/kg | — |
| Subject | SL4903 | Cell therapy | 2e+06 cells/kg | — |
| Subject | SL4903 | Cell therapy | 3e+06 cells/kg | — |