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NOT YET RECRUITING
NCT07599280
PHASE1

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

Sponsor: Jian Zhu

View on ClinicalTrials.gov

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.

Official title: An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Relapsed/Refractory Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-05-11

Completion Date

2028-05-11

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

Universal STAR-T Cell

Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.

Locations (1)

No. 28, Fuxing Road, Haidian District, Beijing, China.

Haidian, Beijing Municipality, China