drugset / Trial / NCT06983964
Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
NaSequentialOpen-labelTreatment
Summary
This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.
Timeline
- Start
- 2025-02-20
- Primary completion
- 2027-02-20
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19 CAR-T | Cell therapy | 500000 cells/kg | — |
| Subject | CD19 CAR-T | Cell therapy | 1e+06 cells/kg | — |
| Subject | CD19 CAR-T | Cell therapy | 2e+06 cells/kg | — |