cGVHD
Conditions
Brief summary
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).
Interventions
BIOLOGICALGT729 Injection
GT729 Injection
Sponsors
Grit Biotechnology
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants experiencing dose limiting toxicity | 28 days | Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion |
| Incidence of adverse events | From infusion to the end of the treatment at 24 months | Incidence of adverse events per NCI-CTCAE version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to 6 months post infusion | 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 |
Countries
China
Contacts
CONTACTErlie Jiang
Outcome results
None listed