drugset / Trial / NCT07604792

FIT-(BCMA+CD19)-CAR-T Cells in Recurrent/Refractory Autoimmune Diseases Patients.

NCT07604792 ↗

Phase 0 Suspended 9 enrolled Beijing Boren Hospital
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

EvaluationDrugModalityDoseRoute
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 —

Indications