NCT04012879Unknown1 期
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- recovery rate of patients being treated with CD19CAR-T
研究概览
简要总结
This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive
- •Age 18 to 65 years old, both male and female;
- •Is expected to survive more than 12 weeks;
- •Physical condition is good: 0-1 score ECOG score;
- •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;
- •Pregnancy and lactation women;
- •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.
研究组 & 干预措施
study group
Experimental
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
干预措施: CD19 CART (Combination Product)
结局指标
主要结局
recovery rate of patients being treated with CD19CAR-T
时间窗: 6 months
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
次要结局
未报告次要终点
研究者
Li Yu
Professor
Chinese PLA General Hospital
研究点 (1)
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