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)

ConditioncGVHD
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrit Biotechnology

About this trial

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 criteria

Qualifiers

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.

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.

Disqualifiers

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

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.

Trial design

Treatments tested in this trial

  • GT729 Injection

Treatment groups

36 Participants
are divided into 1 treatment group

Sponsors and collaborators

Grit Biotechnology

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborator