Universal STAR-T Cell Injection in R/R Autoimmune Diseases.

Summary

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.

Timeline

Start

2026-05-11

Primary completion

2027-05-11

Completion

2028-05-11

Drugs

Indications