An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants with Severe/Adverse Events
研究概览
简要总结
In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.
详细描述
After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Serious cardiac insufficiency, left ventricular ejection fraction<50%;
- •Has a history of severe pulmonary function damaging;
- •Merging other progressing malignant tumor;
- •Merging uncontrolled infection;
- •Merging the metabolic diseases (except diabetes);
- •Merging severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis B or hepatitis C;
- •Patients with HIV infection;
- •Has a history of serious allergies on Biological products (including antibiotics);
- •Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
- •Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
研究组 & 干预措施
volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
干预措施: CD19 CAR-T (Drug)
volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
干预措施: CD22 CAR-T (Drug)
volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
干预措施: CD 19+22 (Drug)
volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
干预措施: Fludarabine (Drug)
volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants with Severe/Adverse Events
时间窗: 28 days
Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis
CAR-T Cell expansion level
时间窗: 24 months
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
次要结局
- Objective response rate of complete remission and partial remission(24 months)
- Overall survival time(24 months)