Single Arm, Two Phase, Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The overall efficiency
研究概览
简要总结
This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia 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 tumour 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 tumour 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 recurrent or refractory acute non T lymphocyte leukemia.The study will be conducted using a phase I/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 24 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
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with acute non T lymphocytic leukemia after conventional treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirm the leukemia cells express can intervene molecular targets;
- •Age 3 to 75 years old, both male and female;
- •Is expected to survive more than 3 months;
- •Physical condition is good: 0-2 score ECOG score;
- •General requirements peripheral blood as basic normal (i.e., white blood cells >= 4.0 x10^9 / L, hemoglobin > 100 g/L, the platelet count>= 50 x10^9 / L ), progress faster, in patients with special severe fully inform the patient related risk and gain understanding and consent, peripheral blood cell index can be extended to white blood cells >= 2.0 x10^9 / L, hemoglobin > 60 g/L, the platelet count >= 30 x10^9 / L. But blood T lymphocytes in peripheral blood count must >=0.2 x10^9 / L;
- •No obvious abnormal heart, liver and kidney function (namely basic normal ecg; kidney function: Cr <=2.0 x ULN (Upper limit of normal value ); liver function: Alt/aspartate aminotransferase acuities <=2.5 x ULN, BIL<= 2.0 x ULN) , no large wounds that haven't healed on the body;
- •Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.
排除标准
- •Various types of T lymphocyte leukemia, etc;
- •Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
- •Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more.
- •Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- •Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution.
- •Coagulation abnormalities and severe thrombosis;
- •Pregnancy and lactation women;
- •Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- •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
The overall efficiency
时间窗: 5 years
The number of complete remission (CR) +The number of complete remission with incomplete hematologic recovery (CRi)/Total number of cases being treated
次要结局
未报告次要终点