drugset / Trial / NCT07604792
FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-center, open-label, single-dose exploration clinical trial for treating patients with partially relapsed/refractory autoimmune diseases by infusing FIT-(BCMA+CD19)-CAR-T cells after pre-treatment with cleansing therapy. In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Timeline
- Start
- 2025-09-25
- Primary completion
- 2025-11-07
- Completion
- 2041-11-30
Outcome
Outcome not reported
Stopped (Enrollment): “Enrollment is suspended to address regulatory requirements. Follow-up of currently enrolled participants continues as planned.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FIT-(BCMA+CD19)-CAR-T Cells | Cell therapy | 100000 cells/kg | — |
| Subject | FIT-(BCMA+CD19)-CAR-T Cells | Cell therapy | 300000 cells/kg | — |
| Subject | FIT-(BCMA+CD19)-CAR-T Cells | Cell therapy | 1e+06 cells/kg | — |