NCT03265106Unknown1 期
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects
Shenzhen BinDeBio 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11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 Participants With Adverse Events [Safety and Feasibility]
研究概览
简要总结
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CD19+ B cell malignancies 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.
- •CD19+ leukemia or lymphoma
- •Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
- •Follicular lymphoma, previously identified as CD19+:
- •Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
- •ECOG result is 0, 1 or
- •With normal heart, liver and kidney functions.
- •Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody for HCV, HIV and syphilis.
- •Negative in pregnancy test (female subject only).
排除标准
- •ECOG result is 3, 4 or
- •Pregnant or lactating female
- •Uncontrolled active infection
- •Active hepatitis B or hepatitis C infection
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- •Previously treatment with any gene therapy products
- •HIV infection
- •Enrolled to other clinical study in the last 4 weeks.
- •Subjects with systemic auto-immune disease or immunodeficiency.
- •Subjects with CNS diseases.
- •Subjects with secondary tumors.
- •Subjects with tumor infiltration in liver, brain or GI tract.
结局指标
主要结局
Number of Participants With Adverse Events [Safety and Feasibility]
时间窗: Study treatment until Week 24
To evaluate the safety and feasibility of BinD19 CAR-T cells in patients with refractory /relapsed B-cell acute lymphoblastic leukemia or lymphoma.
次要结局
- Overall Response [Efficacy](5 years)
研究者
研究点 (1)
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