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| Name | Class |
|---|---|
| The Beijing Pregene Science and Technology Company, Ltd. | INDUSTRY |
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This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR CART) cells in metastatic patients with colorectal cancer.
This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-tumor response of CART-EGFR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR CART | Biological | EGFR CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of study related adverse events as assessed by CTCAE v4.0 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor responses to EGFR CART cells in vivo. | 24 weeks | |
| Determine duration of in vivo survival of EGFR CART . | EGFR CART vector sequences will be determined by Q-PCR | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| geng tian | Contact | 13724395569 | tiangeng666@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| geng tian | Shenzhen Second People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | China |
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