Chimeric Antigen Receptor T Cells Therapy for r/r Malignant Tumors in Children
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ORR3
研究概览
简要总结
This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected survival time ≥ 12weeks
- •At least second-line or above chemotherapy failed
- •Liver and kidney function, heart and lung function meet the following requirements:
- •Creatinine is within the normal range; Left ventricular ejection fraction ≥ 45%; Baseline blood oxygen saturation>91%; Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
- •Understand the trial and have signed the informed consent
排除标准
- •Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
- •Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
- •Severe heart disease
- •Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
- •Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
- •Those who have received CAR-T therapy or other genetically modified cell therapy before screening
- •According to the researcher's judgment, it does not meet the situation of cell preparation
- •Situations that other researchers think are not suitable for inclusion
研究组 & 干预措施
Chimeric antigen receptor T cell
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells
干预措施: CAR-T (Drug)
结局指标
主要结局
ORR3
时间窗: Three months after CAR T cell infusion
3-month objective response rate
次要结局
未报告次要终点