drugset / Trial / NCT07113496
RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
Phase 1
Not yet recruiting
27 enrolled
The First Affiliated Hospital with Nanjing Medical University
NaSingle-groupOpen-labelTreatment
Summary
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
Timeline
- Start
- 2025-08
- Primary completion
- 2027-08
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RN1201 | Cell therapy | — | Intravenous |