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| Name | Class |
|---|---|
| The Pregene (ShenZhen) Biotechnology 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 -IL12 -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. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe 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 |
|---|---|---|---|
| 3 | Experimental | anti-tumor response of EGFR IL12 CART |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR IL12 CART | Biological | EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety: Occurrence of study related adverse events | Occurrence of study related adverse events as assessed by CTCAE v4.0 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Changes of tumor markers | Changes of tumor markers CA-199, AFP and CEA | 24 weeks |
| Effectiveness: duration of in vivo survival of EGFR CART | Determine duration of in vivo survival of EGFR CART |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geng Tian 13724395569 Tiangeng666@Aliyun.Com | Shenzhen | GuangGong | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 1 year |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |