NCT03275493Unknown1 期
Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7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
- 40
- 试验地点
- 1
- 主要终点
- Incidence of severe CRS
研究概览
简要总结
This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
详细描述
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 65
- •Voluntary informed consent is given
- •Expected survival ≥12 weeks
- •Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
- •Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin <2.0 mg/dl (3)Creatinine < 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time < 2 times of ULN (5)Arterial oxygen saturation> 92%
- •Karnofsky score ≥ 60 ;
- •No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;
排除标准
- •Uncontrolled active infections
- •Active hepatitis B or hepatitis C infection
- •HIV infection
- •History of myocardio infarction in the past 6 months, or history of severe arrhythmia
- •Congenital immunodeficiency
- •Pregnant or lactating women
- •History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- •Previous treatment with any gene therapy products
结局指标
主要结局
Incidence of severe CRS
时间窗: 30 days after infusion of CD19 CAR-T cells
The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined
次要结局
- Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.(30 days after infusion of CD19 CAR-T cells)
研究者
研究点 (1)
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