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)

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).

Study Overview

• Status: Recruiting
• Conditions: cGVHD
• Intervention / Treatment: Biological: GT729 Injection

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Erlie Jiang; Phone Number: +8615122538106; Email: Jiangerlie@ihcams.ac.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
      • Principal Investigator: Erlie Jiang
      • Contact: Erlie Jiang; Phone Number: +8615122538106; Email: Jiangerlie@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT729 Injection treatment group; GT729 Injection	Biological: GT729 Injection; GT729 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	To evaluate the percentage of participants who have a confirmed partial response or complete response among total number of evaluable participants as assessed by the investigator	Up to 6 months post infusion

Collaborators and Investigators

• Sponsor: Grit Biotechnology
• Collaborators: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GRIT-CD-CHN-729-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No