NCT02810223Unknown1 期
Efficacy of CART-19 Cell Therapy in B Cell Acute Lymphoblastic Leukemia
Beijing Sanwater Biological Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年5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 single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.
详细描述
This is a single arm, open-label, multi-center, phase I study to determine the efficacy of CTL019 in patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Primary Follow-up, Secondary Follow-up (if applicable) and Survival Follow-up.
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
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CD 19+ B cell acute lymphoblastic leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled
- •Age 1 to 60 years.
- •Expected survival > 12 weeks
- •Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- •ALT ≤ 5x normal
- •Bilirubin <2.0 mg/dl
- •Any relapse after prior SCT will make patient eligible regardless of other prior therapy
- •Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
- •①. Have no active GVHD and require no immunosuppression
- •②. Are more than 4 months from transplant
- •For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
- •Voluntary informed consent is given
- •Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)
排除标准
- •Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- •Uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well
- •Presence of grade 2-4 acute or extensive chronic GVHD
- •Under treatment for GVHD
- •Previous treatment with any gene therapy products
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •HIV infection.
- •CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
结局指标
主要结局
Number of Adverse Events
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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