An Open-Label, Multi-Centre Phase II Study Evaluating the Long-Term Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients Who Have Previously Received ATL001 in a Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Assessment of new malignancies
研究概览
简要总结
This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).
详细描述
Up to 90 patients with advanced non-small cell lung cancer ( NSCLC) or metastatic or recurrent melanoma will be enrolled after either: completing 2 years of follow-up visits in study ATX-NS-001 or study ATX-ME-001; or voluntary withdrawal from these studies prior to the completion of the 2 year of follow-up period.
Each patient will be followed up for a minimum period of 5 years, or until death if sooner, in this Long-Term Follow Up Protocol.
For patients who are still alive after 5 years of follow-up, survival data will continue to be collected until the end of the study, which will occur when the last patient has completed 5 years of follow-up withdraws from study or has died.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients must have given written informed consent to participate in the study.
- •Patients must have received ATL001 in a previous Clinical Trial.
- •Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Assessment of new malignancies
时间窗: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of new malignancies
Assessment of autoimmune adverse events
时间窗: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of autoimmune adverse events
Assessment of the use of medications to manage ATL001-related toxicities
时间窗: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the use of medications to manage ATL001-related toxicities
Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001
时间窗: Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months.
Evaluate the frequency and severity of adverse events related or possibly related to ATL001
次要结局
- Disease Assessment for Progression Free Survival (PFS)(Maximum 60 months.)
- Assessment for Overall Survival (OS)(6 months until death or until the end of the study, whichever came first, assessed up to 84 months)
- Assessment for cancer-related medical resources(Maximum 60 months.)
- Disease Assessment for Duration of Response ( DoR)(Maximum 60 months.)
- Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)(Maximum 60 months.)