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| Name | Class |
|---|---|
| China Immunotech (Beijing) Biotechnology Co., Ltd. | INDUSTRY |
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This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of EBV-TCR-T cells in patients with EB virus infection after HSCT.
EBV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic EBV-TCR-T cell therapy in subjects with EBV infection, patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBV-TCR-T cells | Experimental | Patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV-TCR-T cells | Biological | EBV-TCR-T cells are prepared via lentiviral infection. patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse events | Percentage of participants with adverse events. | 3months |
| Measure | Description | Time Frame |
|---|---|---|
| Proliferation ratio of TCR-T cells | 3months | |
| changes of EBV-DNA copies | 3months |
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Inclusion Criteria:
Exclusion Criteria:
Patients with active aGVHD III-IV and / or mild and severe cGVHD;
Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollmentï¼›
Pregnant or lactating women;
Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
patients with organ failure:
The researchers found that it was unsuitable for the recipients to be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Sanhe | Hebei | 065200 | China |
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