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| Name | Class |
|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT729 Injection treatment group | Experimental | GT729 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT729 Injection | Biological | GT729 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants experiencing dose limiting toxicity | Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion | 28 days |
| Incidence of adverse events | Incidence of adverse events per NCI-CTCAE version 5.0 | From infusion to the end of the treatment at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months post infusion |
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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:
The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erlie Jiang | Contact | +8615122538106 | Jiangerlie@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
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