Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
This is an open, single-arm, prospective，clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
详细描述
A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
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
- •Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- •Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
- •Age: 1-18 years (including boundary value), both male and female;
- •Subjects with Lansky score ≥ 50;
- •The results of treatment-related antigens were positive;
- •The expected survival time is more than 3 months from the date of signing the informed consent.
排除标准
- •Severe cardiac insufficiency and left ventricular ejection fraction < 50%;
- •He had a history of severe lung function damage;
- •Combined with other advanced malignant tumors;
- •Severe infection was found and could not be effectively controlled;
- •With metabolic diseases (except diabetes mellitus);
- •Combined with severe autoimmune disease or congenital immunodeficiency;
- •Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [HCV AB] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- •Severe allergy history of biological products (including antibiotics);
- •Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
- •The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.
研究组 & 干预措施
Auto CAR-T
Patients will be treated with Auto CAR-T cells
干预措施: Auto CAR-T (Biological)
Auto CAR-T
Patients will be treated with Auto CAR-T cells
干预措施: Cyclophosphamide,Fludarabine (Drug)
Auto CAR-T
Patients will be treated with Auto CAR-T cells
干预措施: Leukapheresis (Procedure)
结局指标
主要结局
Safety: Incidence and severity of adverse events
时间窗: First month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
时间窗: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、partial response(PR)、No remission(NR)、progressive disease(PD)
次要结局
- Efficacy:duration of response (DOR)(24 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)