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This single-arm, multicenter Phase 2 trial will treat the patients who have relapsed or refractory stomach cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR) that will bind to tumor cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumor cells.The trial will also study the safety of treatment with CAR-T, how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
This is a single-arm, multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Stomach Cancer. The study will be conducted using a phaseâ… /â…¡ design.The study will have the following sequential phases: Part A(screening leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B(treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion.The total duration of the study is expected to be approximately 3 years. A total of 19 patients may be enrolled over a period of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:0days,the first day,the second day,28 days,29 days Duration:total five times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPCAM-targeted CAR-T cells | Biological | This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rates | 0 to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of remission | 0 to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifu He, PI | Contact | 18963789042 | 834638033@qq.com | |
| Jian Chen, Investigator | Contact | 15395000136 | 42002390@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifu He, PI | Associate chief physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | 230071 | China |
No plans to share data.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |