NCT02968472Unknown1 期
Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
The First People's Hospital of Yunnan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3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
- 30
- 试验地点
- 1
- 主要终点
- Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
研究概览
简要总结
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged more than 6 months.
- •the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules.
- •the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months.
- •the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less.
- •or greater Hgb 80 g/L.
- •no contraindications to solid and cell separation
- •the patient and family to have a strong willingness to participate in clinical trials, and are willing to bear all the consequence caused by the test failed, and sign the informed consent.
- •the panel discussion, combined with patient general condition, think the benefit is greater than the risks involved in the clinical trials.
排除标准
- •accompanied with other active disease, the treatment is difficult to correct.
- •bacteria, fungus, or virus infection, unable to control.
- •people living with HIV.
- •active hepatitis B virus and hepatitis C virus infection.
- •of pregnancy and nursing mothers.
- •before entering the test of the use of glucocorticoid systemic treatment within a week.
- •confirmed before used CAR - but invalid patients treated T cells, after in the physical examination, experts discuss confirmed by a team doesn't fit in the CAR again - T treatment.Before used gene therapy method.
- •the researchers believe that might increase risk subjects or interfere with the test results of any situation.
结局指标
主要结局
Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
时间窗: 24 weeks
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
次要结局
- Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)(1 year)
研究者
Xun Lai
chief physician
The First People's Hospital of Yunnan
研究点 (1)
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