MedTrace Logo

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

NCT07599280 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • China Immunotech (Beijing) Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Jian Zhu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2027-05-11
Completion
2028-05-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599280 on ClinicalTrials.gov