Single-arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Stomach Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Disease control rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Age <=75 years old, both male and female;
- •Is expected to survive more than 3 months;
- •Physical condition is good: 0-2 score ECOG score;
- •The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood;
- •Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;
- •Non pregnancy and lactation;
- •History of severe allergic reactions without biological products;
- •Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;
- •At least one measurable lesion.
排除标准
- •Pregnant or lactating women;
- •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;
- •Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- •Long term use of immunosuppressive drugs or people with severe autoimmune diseases;
- •Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- •A serious infectious disease with severe, uncontrollable, wound healing
- •Allergy to the interleukin and interferon cytokine;
- •Coagulation abnormalities and severe thrombosis;
- •Patients who have participated in other clinical trials or other clinical trials in the past 30 days
- •The Investigator believe the patients should not participate in this experiment.
结局指标
主要结局
Disease control rates
时间窗: 0 to 180 days
次要结局
- Duration of remission(0 to 180 days)