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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
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This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include four different tumor-specific antibody.They are as following:anti-NY-ESO-1 antibody foresophagus cancer;anti-DR5 antibody for hepatoma;;anti-EGFR vIII antibody for hepatoma and glioma;anti-Mesothelin antibody for gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T/TCR-T cells immunotherapy | Experimental | Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T/TCR-T cells immunotherapy | Biological | According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 | Safety evaluation | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging. | 48 months |
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Inclusion Criteria:
In addition to the above criteria for inclusion, the following criteria shall be met according to the indications:
Patients with glioblastoma:
Patients with liver cancer
Patients with gastric cancer
Patients with esophageal cancer
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHONG HUA YANG | Contact | +8618938688105 | +8618938688105 | zh.yang@bindebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D005910 | Glioma |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D013272 | Stomach Diseases |