study evaluating the efficacy and safety with car-t for stomach cancer

Conditions: Stomach Neoplasms

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.

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.

Eligibility 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.

Keywords: stomach cancer car-t