NCT06920199

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.In this study, rapid titration of the first dose group and a "3+3" rule design were used for dose escalation to minimize patient exposure to ineffective doses while minimizing the occurrence of risk.Three dose groups were set up: 1×10\^6 Treg cells /kg dose group, 5.0×10\^6 Treg cells /kg dose group and 10×10\^6Treg cells /kg dose group.One infusion per dose group.

Conditions

• cGVHD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-14
• Primary completion: 2027-05-15
• Completion: 2027-09-15
• First posted: 2025-04-09
• Last updated: 2025-09-30

Locations

1 site across 1 country: China