drugset / Trial / NCT06686524
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)
NaSingle-groupOpen-labelTreatment
Summary
This study is an open-label, single-arm, dose-escalation trial primarily designed to evaluate the safety and efficacy of a universal CAR-T cell therapy targeting CD19 in the treatment of patients with RJDM. Additionally, the study aims to characterize its pharmacokinetic and pharmacodynamic properties, explore its role in immune system reconstitution, and assess long-term survival benefits.
Timeline
- Start
- 2024-11-11
- Primary completion
- 2026-11-10
- Completion
- 2027-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 3e+07 cells/kg | Intravenous |
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 6e+07 cells/kg | Intravenous |