RecruitingEarly Phase 1NCT06920199

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

Clinical Study to Evaluate the Safety and Efficacy of Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2 in the Treatment of Refractory cGVHD Subjects

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

18 participants

Start Date

Jun 14, 2025

Study Type

INTERVENTIONAL

Conditions

cGVHD

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Donor-derived Treg cell injection combined with interleukin 2 for people with cgvhd. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDonor-derived Treg cell injection combined with interleukin 2

Subjects received Treg cell infusion at day D0, and interleukin 2 was administered subcutaneously daily from 1 week before to 12 weeks after infusion.