Actively Recruiting
A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)
Led by Grit Biotechnology · Updated on 2026-04-14
36
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
I
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of GT729 universal cell injection for treating patients with refractory or relapsed chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation. This early phase 1 clinical trial aims to understand how this biological treatment affects people who have not responded to at least two prior systemic therapies for active cGVHD. Participants will receive the GT729 injection as the experimental treatment. The study will monitor participants from the time of infusion through 24 months to assess safety outcomes such as dose limiting toxicity within 28 days and the occurrence of adverse events. Researchers will also evaluate the overall response rate up to 6 months after the infusion. During the study, participants will undergo regular assessments including laboratory tests to monitor blood counts, liver and kidney function, and pregnancy status for women of childbearing age. Safety and treatment response will be closely observed throughout the treatment period. The total participation duration may last up to two years for long-term safety monitoring and outcome evaluation.
CONDITIONS
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legal representatives voluntarily sign a written informed consent form and agree to follow study procedures.
- Age between 18 and 65 years old at consent, any gender.
- Allogeneic hematopoietic stem cell transplant recipients with active chronic graft-versus-host disease requiring systemic immunosuppressive therapy.
- Have refractory or relapsed active cGVHD after at least two lines of systemic treatment.
- Laboratory tests must meet these: neutrophil count ≥ 1.0×10⁹/L; hemoglobin ≥ 80g/L; platelet count ≥ 30×10⁹/L; liver enzymes ≤ 3× upper limit of normal; total bilirubin < 2× upper limit of normal; creatinine clearance ≥ 30 mL/min.
- Women of childbearing age must have a negative pregnancy test at screening.
You will not qualify if you...
- Evidence of recurrence of original cancer or post-transplant lymphoproliferative disorder at screening.
- History of severe allergies or hypersensitivity.
- Severe heart disease such as NYHA Class III/IV heart failure or recent myocardial infarction or coronary surgery within 6 months.
- Clinically significant bleeding or bleeding tendency within 6 months prior to screening.
- Severe underlying medical conditions at screening.
- Major surgery within 8 weeks before screening or planned surgery during the study.
- History of organ transplantation.
- Any condition that may prevent completion of the trial, confuse results, or not be in the participant's best interest as judged by the investigator.
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 - Up to 24 months
Participants receive GT729 universal cell injections to treat refractory or relapsed chronic graft-versus-host disease (cGVHD).
Visits from infusion until the end of treatment at 24 months
Duration - Up to 6 months post infusion
Participants are monitored for safety and treatment response after the GT729 injection.
Visits up to 6 months after infusion
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
E
Erlie Jiang
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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