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| Name | Class |
|---|---|
| Shenzhen Geno-Immune Medical Institute | OTHER |
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A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically, which summarizes the best therapeutic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prophylactic 4SCAR19 cells | Experimental | Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prophylactic 4SCAR19 cells | Genetic | Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells. | Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lai Xun, Doctor | Contact | 13577096609 | 1729112214@qq.com | |
| Chang Lung-Ji, Doctor | Contact | 13671121909 | longflorida@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Huang Jianzhang, Doctor | Shenzhen immune gene therapy research institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First people's hospital of Yunnan province | Recruiting | Kunming | Yunnan | NCT650000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32772769 | Derived | Lai X, Sun YY, Chang LJ, Ma YR, Gu XZ, Yao XM, Nie B, Wen Y, Zhang XM, Jiang YX, Yang H, Yu LQ, Fang MJ, Wang L, Yuan Bo X. Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy? Bioengineered. 2020 Dec;11(1):824-828. doi: 10.1080/21655979.2020.1791597. |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |