Actively Recruiting
Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-09-30
18
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Subjects aged 18 to 70 years, male or female
- Have received allogeneic hematopoietic stem cell transplantation (allo-HSCT), including cord blood transplantation
- Moderate or severe chronic graft-versus-host disease (cGVHD) meeting NIH diagnostic criteria for steroid dependence or resistance
- No improvement in cGVHD after initial steroid treatment of >0.5 mg/kg/day prednisone for at least 4 weeks, or steroid dependence with relapse or progression when reducing prednisone
- Prednisone dose >0.25 mg/kg/day for more than 4 weeks and stable for 4 weeks before first Treg infusion
- No increase or discontinuation of other immunosuppressants before infusion
- ECOG performance status score of 0 to 2
- Expected survival longer than 3 months
- Liver, kidney, heart, and lung function within specified limits, allowing dysfunction caused by cGVHD
- Hematopoietic function with neutrophils >1 x 10^9/L and platelets >25 x 10^9/L without supportive treatments
- Subject or guardian understands the study and has signed informed consent
- Donor aged 14 to 70 years, male or female
- Donor with ECOG score 0 to 1
- Donor underwent allo-HSCT prior to subject
- Female donors test negative for pregnancy within 3 weeks before blood collection
- Donor able to establish venous access for collection and consents to donation
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 >1 mg/kg/day
- Unable to assess cGVHD severity by examination or lab tests
- Overlap syndrome
- Major organ dysfunction not caused by cGVHD, including recent gastrointestinal bleeding, uncontrolled hypertension, significant cardiovascular or cerebrovascular disease, recent thrombosis or embolism
- Hemodialysis treatment
- Active, uncontrolled bacterial, viral, or fungal infection requiring treatment
- Pregnancy or breastfeeding, or planning pregnancy during or within 1 year after study
- Received IL-2 or IL-2 targeted therapy within 4 weeks before enrollment
- Received donor lymphocyte infusion (DLI) or CAR-T therapy within 100 days before enrollment
- Received new cGVHD therapies (e.g., imatinib, BTK inhibitors, rituximab) within 4 weeks before enrollment
- History of microvascular diseases such as thrombotic microangiopathy, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura
- Poor compliance with IL-2 treatment
- Participation in other cGVHD clinical studies within 4 weeks before enrollment
- Known allergy to any component of Treg cell injection
- Any condition that compromises safety or study participation
- Unable or unwilling to provide informed consent or follow study procedures
- Donor is pregnant woman
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
X
xianmin song, Doctor
CONTACT
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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