NCT02666248已完成不适用
Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv Chimeric Antigen Receptor (CAR).
详细描述
The primary objective of this study is to monitor adult subjects, who as participants of a clinical trial, received T cells modified by a lentiviral vector encoding a chimeric antigen receptor specific for EGFRvIII, for adverse events that may be associated with lentiviral vector gene transfer such as insertional oncogenesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be enrolled into this destination protocol because they have received CART-EGFRvIII cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND 15968 and have received CART-EGFRvIII cells will be asked to participate in this protocol.
- •Subjects 18 years of age and older
- •Subjects who have provided informed consent prior to their study participation.
排除标准
- 未提供
结局指标
主要结局
Number of adverse events
时间窗: 15 years
次要结局
未报告次要终点
研究者
研究点 (2)
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