Actively Recruiting
Clinical Study to Evaluate the Safety and Efficacy of Donor-derived Treg Cell Injection Combined with Recombinant Human Interleukin-2 for Refractory cGVHD
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-09-30
18
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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 × 10^6, 5.0 × 10^6, or 10.0 × 10^6 cells per kg of body weight) following a dose-escalation design. They also receive daily subcutaneous injections of interleukin-2 at 1 million IU/m2 for 13 weeks, starting one week before the Treg cell infusion. The study uses a "3+3" 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 treatment's longer-term impact.
CONDITIONS
Brief Title
Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 70 years, male or female
- Received allogeneic hematopoietic stem cell transplantation, including cord blood transplant
- Moderate or severe chronic graft-versus-host disease (cGVHD) meeting NIH criteria with steroid dependence or resistance
- Prednisone dose greater than 0.25 mg/kg/day for more than 4 weeks, stable for 4 weeks before treatment
- ECOG performance status of 0 to 2
- Expected survival of more than 3 months
- Adequate liver, kidney, heart, and lung function as specified, excluding dysfunction caused by cGVHD
- Neutrophils above 1×10^9/L and platelets above 25×10^9/L without supportive treatments
- Ability to understand the study and provide informed consent
- Donor aged 14 to 70 years, male or female, with ECOG 0 to 1
- Donor must have undergone allogeneic hematopoietic stem cell transplant prior to donation
- Female donors must have negative pregnancy test within 3 weeks before collection
- Donor able to provide necessary venous access and willing to donate with signed consent
You will not qualify if you...
- Recurrence of primary malignant disease before Treg treatment
- Persistent, recurrent, or delayed acute graft-versus-host disease (aGVHD)
- Continuous use of prednisone over 1 mg/kg/day
- Inability to assess cGVHD severity by examination or lab tests
- Overlap syndrome
- Significant organ dysfunction not caused by cGVHD, recent major bleeding, or serious cardiovascular or cerebrovascular conditions
- Hemodialysis treatment
- Active, uncontrolled infections requiring treatment
- Pregnant or breastfeeding women, or planning pregnancy during or within 1 year after study
- Prior IL-2 or IL-2 targeting therapy within 4 weeks before enrollment
- Donor lymphocyte infusion (DLI) or CAR-T therapy within 100 days before enrollment
- Recent new cGVHD therapies within 4 weeks before enrollment
- History of microvascular diseases like thrombotic microangiopathy
- Poor compliance with IL-2 treatment
- Participation in other cGVHD clinical trials within 4 weeks before enrollment
- Known allergy to any component of the Treg cell injection
- Any condition or situation deemed unsafe or inappropriate by the investigator
- Inability to provide informed consent or follow study procedures
- Donor who is pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 weeks
Participants receive a single infusion of donor-derived Treg cells and daily subcutaneous injections of interleukin 2 starting one week before infusion and continuing for 12 weeks after.
1 infusion visit and daily injections for 13 weeks with regular visits for monitoring
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and long-term outcomes related to treatment.
Periodic visits for assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
X
xianmin song, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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