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| Name | Class |
|---|---|
| The Second Hospital of Anhui Medical University | OTHER |
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This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for recurrent or refractory acute non T lymphocyte leukemia.The study will be conducted using a phase I/II design.The study will have the following sequential phases:Part A (screening leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study is expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-targeted CAR-T cells | Biological | This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months.. |
| Measure | Description | Time Frame |
|---|---|---|
| The overall efficiency | The number of complete remission (CR) +The number of complete remission with incomplete hematologic recovery (CRi)/Total number of cases being treated | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhimin Zhai, Professor | Chief physician | Principal Investigator |
| Hui Liao, Doctor | Chief physician | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| No. 454 Hospital of People'S Liberation Army |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33230103 | Derived | An F, Wang H, Liu Z, Wu F, Zhang J, Tao Q, Li Y, Shen Y, Ruan Y, Zhang Q, Pan Y, Zhu W, Qin H, Wang Y, Fu Y, Feng Z, Zhai Z. Influence of patient characteristics on chimeric antigen receptor T cell therapy in B-cell acute lymphoblastic leukemia. Nat Commun. 2020 Nov 23;11(1):5928. doi: 10.1038/s41467-020-19774-x. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Nanjing |
| Jiangsu |
| 210000 |
| China |