Clinical Trial

Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2

Recruiting Early Phase 1
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Summary
This study is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, tolerability, changes and persistence of peripheral blood Treg cells, and pharmacodynamic characteristics of donor-derived Treg cell injection combined with recombinant human interleukin-2 in treating subjects with refractory cGVHD，and to preliminarily observe the efficacy of the study drugs in subjects with refractory cGVHD.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-02.
Status change: Not Yet Recruiting → Recruiting 2025-09-28
Trial Details
NCT Number NCT06920199
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions cGVHD
Enrollment 18 participants
Start Date 2025-06-14
Primary Completion 2027-05-15 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-30