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 | Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-729-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

cGVHD

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing dose limiting toxicity

  Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion

  28 days

• Incidence of adverse events

  Incidence of adverse events per NCI-CTCAE version 5.0

  From infusion to the end of the treatment at 24 months

Secondary Outcomes (1)

• Overall response rate (ORR)

  Up to 6 months post infusion

Study Arms (1)

GT729 Injection treatment group

EXPERIMENTAL

GT729 Injection

Biological: GT729 Injection

Interventions

GT729 Injection BIOLOGICAL

GT729 Injection

GT729 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• The subjects are allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic graft-versus-host disease (active cGVHD) requiring systemic immunosuppressive therapy.
• 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):
• Neutrophil count ≥ 1.0×10⁹/L;
• Hemoglobin ≥ 80g/L; Platelet count ≥ 30×10⁹/L;
• Alanine transaminase ≤ 3×upper limit of normal (ULN); Aspartate transaminase ≤ 3×ULN; Total bilirubin (TBIL) \< 2×ULN;
• Creatinine clearance rate ≥ 30 mL/min.
• Women of childbearing age must:
• At the time of screening, as confirmed by the investigator, the result of the serum β-human chorionic gonadotropin (β-hCG) pregnancy test is negative.

You may not qualify if:

• 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:
• New York Heart Association (NYHA) Class III or IV congestive heart failure;
• 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.

Sponsors & Collaborators

• Grit Biotechnology: lead
• Institute of Hematology & Blood Diseases Hospital, China: collaborator

Study Sites (1)

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

Tianjin, Tianjin Municipality, China

RECRUITING

Central Study Contacts

Erlie Jiang

CONTACT

+8615122538106; Jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)