Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT07253259

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

158 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

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

Official 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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants or their legal representatives voluntarily sign a written informed consent form and agree to comply with study procedures.
  • Aged between 18 and 65 years old at the time of consent, regardless of gender.
  • Allogeneic hematopoietic stem cell transplantation recipients with active chronic graft-versus-host disease requiring systemic immunosuppressive therapy.
  • Patients with refractory or relapsed active cGVHD after at least two lines of systemic treatment.
  • Screening laboratory results must meet the following (excluding disease-related indicators): neutrophil count ≥ 1.0×10⁹/L; hemoglobin ≥ 80g/L; platelet count ≥ 30×10⁹/L; alanine transaminase ≤ 3× upper limit of normal; aspartate transaminase ≤ 3× upper limit of normal; total bilirubin < 2× upper limit of normal; creatinine clearance rate ≥ 30 mL/min.
  • Women of childbearing age must have a negative serum β-human chorionic gonadotropin pregnancy test at screening as confirmed by the investigator.
Not Eligible

You will not qualify if you...

  • Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder at screening.
  • History of severe hypersensitivity or allergies.
  • Heart diseases including New York Heart Association Class III or IV congestive heart failure, or myocardial infarction or coronary artery bypass surgery within 6 months before screening.
  • Clinically significant bleeding symptoms or clear bleeding tendency within 6 months prior to screening.
  • Severe underlying medical conditions at screening.
  • Major surgery within 8 weeks prior to screening or planned surgery during the study period.
  • History of organ transplantation.
  • Any condition that, in the investigator's opinion, would prevent completion of the trial, confuse results, or not be in the best interest of the participant.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

E

Erlie Jiang

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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