Clinical Trial

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

Suspended Early Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
Enrollment is suspended to address regulatory requirements. Follow-up of currently enrolled participants continues as planned.
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.
Protocol Amendment History 2 changes
critical Trial status changed: Enrolling by Invitation → Suspended 2026-07-07
critical Primary endpoint(s) modified 2026-05-30
Trial Details
NCT Number NCT07604792
Lead Sponsor Beijing Boren Hospital
Conditions Autoimmune Diseases
Enrollment 9 participants
Start Date 2025-09-25
Primary Completion 2025-11-07 (estimated)
Study Completion 2041-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-06