Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Long-term safety study is to follow up subjects treated with CTX0E03 DP
研究概览
简要总结
The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival
详细描述
The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent
排除标准
- 未提供
结局指标
主要结局
Long-term safety study is to follow up subjects treated with CTX0E03 DP
时间窗: 4 Years
Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival.
次要结局
未报告次要终点