drugset / Trial / NCT06686524

Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)

NCT06686524

Phase 1 Recruiting 18 enrolled Chongqing Precision Biotech Co., Ltd
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

EvaluationDrugModalityDoseRoute
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