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This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chimeric antigen receptor T cell | Experimental | Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Drug | The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR3 | 3-month objective response rate | Three months after CAR T cell infusion |
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Inclusion Criteria:
Creatinine is within the normal range; Left ventricular ejection fraction ≥ 45%; Baseline blood oxygen saturation>91%; Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ShaoYan Hu | Contact | 137-7187-0462 | hushaoyan@suda.edu.cn | |
| HuiMin Meng | Contact | 188-9680-2149 | huimin.meng@persongen.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chilren's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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