Brief Summary:

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.

Stomach Neoplasms

Biological: EPCAM-targeted CAR-T cells

Detailed Description:

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 phaseⅠ /Ⅱ 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.

Arms and Interventions

Arm

Experimental: Single-arm

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

Intervention

Biological: EPCAM-targeted CAR-T cells

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-Tcells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.

Primary Outcome Measures  :

1. Disease control rates [ Time Frame: 0 to 180 days ]

Secondary Outcome Measures  :

1. Duration of remission [ Time Frame: 0 to 180 days ]

Criteria

Inclusion Criteria:

1.     According to UICC or gastric cancer diagnosis and treatment guideline of diagnosis for patients with gastric cancer, first-line and second-line chemotherapy of advanced gastric cancer, and through flow cytometry or immune tissues (cell) chemistry, confirm the tumor cells positive expression of relevant molecular targets;

2.     Age <=75 years old, both male and female;

3.     Is expected to survive more than 3 months;

4.     Physical condition is good: 0-2 score ECOG score;

5.     The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood;

6.     Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;

7.     Non pregnancy and lactation;

8.     History of severe allergic reactions without biological products;

9.     Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;

10. At least one measurable lesion.

Exclusion Criteria:

1.     Pregnant or lactating women;

2.     Organ failure, such as heart: Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;

3.     Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;

4.     Long term use of immunosuppressive drugs or people with severe autoimmune diseases;

5.     Any other chronic disease patients who have been treated with immune agents or hormone therapy;

6.     A serious infectious disease with severe, uncontrollable, wound healing

7.     Allergy to the interleukin and interferon cytokine;

8.     Coagulation abnormalities and severe thrombosis;

9.     Patients who have participated in other clinical trials or other clinical trials in the past 30 days

10. The Investigator believe the patients should not participate in this experiment.