drugset / Trial / NCT07114432
RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma
Phase 1
Not yet recruiting
19 enrolled
Tianjin Medical University Cancer Institute and Hospital
Allorunning Therapeutics · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed cytogenetically high-risk multiple myeloma who are ineligible or unwilling to undergo autologous stem cell transplantation (ASCT). Patients will receive lymphodepletion followed by a single infusion of RN1201 across four dose levels. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
Timeline
- Start
- 2025-08
- Primary completion
- 2027-12
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RN1201 | Cell therapy | — | — |