NCT04762485Unknown1 期
Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
详细描述
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute 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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed CD7 positive relapsed/refractory acute leukemia.
- •Age 12-65 years.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •CD7 on leukemia is >30% positive detected with flow cytometry.
- •Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- •Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
排除标准
- •Patients are pregnant or lactating
- •Patients with congenital immunodeficiency.
- •Patients with central nervous system leukemia.
- •Patients with uncontrolled active infection.
- •Patients with active hepatitis B or hepatitis C infection.
- •Patients with HIV infection.
- •Patients with atrial or venous thrombosis or embolism.
- •Patients with myo-infarction or severe arrythmia in the recent 6 months.
- •Other comorbidities that investigators considered not suitable for this study.
结局指标
主要结局
Number of Adverse Events
时间窗: 12 months
Adverse events are evaluated with CTCAE V5.0
次要结局
- the duration of CAR T-cells in vivo(2 years)
- Overall response rate (ORR)(2 years)
- Cumulative incidence of relapse(CIR)(2 years)
研究者
研究点 (1)
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