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
Sponsors and collaborators
Grit Biotechnology
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborator