NCT05381662招募中1 期
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年8月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 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 combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .
详细描述
Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell( CAR-T) and CD19-positive T cells.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65
- •Voluntary informed consent is given
- •Expected survival ≥12 weeks
- •Relieve CD19+ acute leukemia
- •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: 12 months
The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated
次要结局
未报告次要终点
研究者
研究点 (3)
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