NCT03156101Unknown1 期
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory 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 24 人开始时间: 2017年3月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 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 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
- 4 Years 至 70 Years（Child, Adult, Older 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 antibody for EBV, CMV, HBV, HCV, HIV and syphilis.
- •Negative in pregnancy test （female subject only).
排除标准
- •ECOG result is 3, 4 or
- •Pregnant or lactating women
- •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
Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
次要结局
- Overall Response [Efficacy](5 years)
研究者
研究点 (1)
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