Study of Donor-Derived Treg Cell Injection with Recombinant Human Interleukin-2 for Treating Adults with Resistant cGVHD

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of donor-derived regulatory T Treg cell injections combined with recombinant human interleukin-2 in adults with refractory chronic graft-versus-host disease cGVHD. This early-phase, single-arm, open-label study aims to observe changes in peripheral blood Treg cells and preliminary effectiveness of the treatment in this difficult-to-treat condition. Participants receive one infusion of donor-derived Treg cells at one of three doses 1.0 106, 5.0 106, or 10.0 106 cells per kg of body weight following a dose-escalation design. They also receive daily subcutaneous injections of interleukin-2 at 1 million IUm2 for 13 weeks, starting one week before the Treg cell infusion. The study uses a 33 dose escalation method to reduce risk and limit exposure to ineffective doses. During the study, participants are closely monitored for safety, including adverse reactions up to two years after treatment. Researchers measure changes in Treg cell numbers, lymphocyte subsets, and cGVHD severity, and collect patient-reported outcomes and quality of life assessments. Steroid dosage reduction and survival outcomes are tracked over an average of two years to evaluate the treatments longer-term impact.

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