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RECRUITING
NCT06920199
EARLY_PHASE1

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-06-14

Completion Date

2027-09-15

Last Updated

2025-09-30

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Donor-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.

Locations (1)

Shanghai General Hospital

Shanghai, China