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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) | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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)

NCT07253259•Grit Biotechnology

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to evaluate the safety and efficacy of GT729 universal cell injection in the treatment of refractory or relapsed chronic graft-versus-host disease (cGVHD).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants or their legal representatives voluntarily sign a written informed consent form, are willing and able to comply with the procedures of this study.
•Aged 18 to 65 years old (inclusive) when signing the informed consent, regardless of gender.
•Participants must meet the following criteria:
•1. The subjects are allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic graft-versus-host disease (active cGVHD) requiring systemic immunosuppressive therapy.
•2. The subjects are patients with refractory or relapsed active cGVHD after receiving at least two lines of systemic treatment.
•The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):
•1. Neutrophil count ≥ 1.0×10⁹/L;
•2. Hemoglobin ≥ 80g/L; Platelet count ≥ 30×10⁹/L;
•3. Alanine transaminase ≤ 3×upper limit of normal (ULN); Aspartate transaminase ≤ 3×ULN; Total bilirubin (TBIL) \< 2×ULN;
•4. Creatinine clearance rate ≥ 30 mL/min.
+2 more criteria

Exclusion Criteria

•Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening
•Having a history of severe hypersensitivity or allergies
•Suffering from the following heart diseases:
•1. New York Heart Association (NYHA) Class III or IV congestive heart failure;
•2. A myocardial infarction occurred or coronary artery bypass surgery was performed within 6 months before the screening period.
•Participants with clinically significant bleeding symptoms or a clear bleeding tendency within the 6 months prior to screening;
•Participants with severe underlying medical conditions at the time of screening;
•Participants who have undergone major surgery within 8 weeks prior to screening or are scheduled to undergo surgery during the study period;
•History of organ transplantation;
•According to the investigator's judgment, there are circumstances that would prevent the participant from completing the entire trial, confuse the trial results, or make participation in the trial not in the best interest of the participant.

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 1, 2025

Primary Completion Date

November 30, 2027

Completion Date

December 31, 2028

Last Updated

November 28, 2025

Enrollment

ESTIMATED participants

Conditions

cGVHD

Interventions

GT729 Injection

BIOLOGICAL

Contacts

Erlie Jiang

CONTACT

+8615122538106 Jiangerlie@ihcams.ac.cn

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Chronic Graft-versus-host Disease (cGVHD)

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ENROLLING_BY_INVITATIONPHASE2

A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)

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NOT_YET_RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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