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).
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.
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.
Single group
GT729 Injection
Biological/VaccineGT729 Injection
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence of adverse events
Incidence of adverse events per NCI-CTCAE version 5.0
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
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Grit Biotechnology
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborator
