A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-65
- •Sign informed consent
- •Expected survival time ≥ 3 months
- •CD7 positive refractory and relapsed acute leukemia
- •Karnofsky score≥60
- •ECOG score ≤ 2
- •Have not received other immunotherapy within 3 months
- •The CD7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30%
排除标准
- •Uncontrolled active infection
- •Active viral hepatitis B or C
- •HIV test positive
- •Congenital immunodeficiency patients
- •Pregnant and breastfeeding patients
- •Patients with central nervous system tumors or central nervous system leukemia
- •The patient and/or family members do not agree to the treatment plan
研究组 & 干预措施
T cell injection targeting CD7 chimeric antigen receptor
干预措施: T cell injection targeting CD7 chimeric antigen receptor (Drug)
结局指标
主要结局
DLT
时间窗: Up to 2 years
Dose-limiting toxicity
次要结局
- PD(Up to 2 years)
- Safety results(Up to 2 years)
- PK(Up to 2 years)