Single Arm, Two Phase, Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Objective Reaction Rates
研究概览
简要总结
This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or refractory diffuse large B cell lymphoma 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 diffuse large B cell lymphoma.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
- •Confirmed by pathological biopsy in patients with diffuse large B cell lymphoma by standard solution treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirmed the tumor cell surface expression positive intervention molecular targets, mainly for the CD19 (+) and/or CD20 (+).
- •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;
- •In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
- •General requirements peripheral blood as basic, normal blood T lymphocytes in peripheral blood count must >= 0.2 x10^9 / L;
- •No obvious abnormal heart, liver, kidney, 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
- •The recurrent or refractory patients with diffuse large B cell lymphoma.
- •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
Objective Reaction Rates
时间窗: 0 to 180 days
次要结局
未报告次要终点