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| Name | Class |
|---|---|
| Shanghai GeneChem Co., Ltd. | INDUSTRY |
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The purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver metastases expressing MG7 positively.
Designer T cells are prepared by PBMC which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs) specific for MG7, which is a glycosylated protein of CEA. Cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 CAR positive T cells. The cells perfusion process would last for 1min to 2min. The dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG7-CART | Experimental | A single dose of MG7-CART cells will be administered by intra-tumor injection under ultrasound guidance. The dose is 1-6x108 MG7-CAR positive T cells. The infusion will be scheduled to occur 2 days after two doses of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures. The cells perfusion process would lasts 1min to 2min, and an interventional radiologist would operate the cell infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG7-CART | Biological | Ultrasound-guided intra-tumor injection as the route of T cell delivery, so that more T cells gathered at the tumor site, less migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And MG7-CART is a 2nd CAR, with MG7 as the target protein, 4-1BB as co- stimulator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse event | adverse event is evaluated with CTCAE, version 4.0 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with tumor response | summarize tumor response by overal response rates | 8 weeks |
| Detection of transferred T cells in the circulation using quantitative -PCR | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongzhan Nie, Doctor | Contact | yongznie@fmmu.edu.cn | ||
| Xuejun Yu, Master | Contact | 86-18616108610 | yuxuejun@genechem.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongzhan Nie, Doctor | Xijing Hospital of Digestive Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Recruiting | Xi'an | Shaanxi | 701032 | China |
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