drugset / Trial / NCT06892145
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
Phase 1
Recruiting
12 enrolled
Chongqing Precision Biotech Co., Ltd
Second Affiliated Hospital, School of Medicine, Zhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
Timeline
- Start
- 2025-06-12
- Primary completion
- 2026-05-04
- Completion
- 2028-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MC-1-50 | Cell therapy | 30000 cells/kg | Intravenous |
| Subject | MC-1-50 | Cell therapy | 100000 cells/kg | Intravenous |
| Subject | MC-1-50 | Cell therapy | 300000 cells/kg | Intravenous |