CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.
详细描述
Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.
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
- 18 Years 至 75 Years（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 B-cell malignancies and treated by autologous stem cell transplantation.
- •Age 18 to 75 years old, both male and female;
- •Is expected to survive more than 3 months;
- •Physical condition is good: ECOG score≤2;
- •In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
- •General requirements autologous as basic, normal blood T lymphocytes in autologous 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
- •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
Progress-free survival
时间窗: 2 years
Objective response rate
时间窗: 2 years
Disease control rate
时间窗: 2 years
Overall survival
时间窗: 2 years
次要结局
未报告次要终点