Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Outcome of Clinically Significant CEI
研究概览
简要总结
The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:
- What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
- What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
详细描述
This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.
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
- •Receipt of at least 1 dose of azer-cel in an Imugene clinical study.
- •A signed informed consent form (ICF).
- •Willingness and ability to adhere to the study schedule and all other protocol requirements.
排除标准
- •No unique exclusion criteria apply to this study.
结局指标
主要结局
Outcome of Clinically Significant CEI
时间窗: Up to 15 years
Severity of Clinically Significant CEI
时间窗: Up to 15 years
Duration of Clinically Significant CEI
时间窗: Up to 15 years
Frequency of Clinically Significant Clinical Events of Interest (CEI)
时间窗: Up to 15 years
次要结局
- Duration of Disease Response(Up to 15 years)
- Azer-cel Persistence(Up to 15 years)
- Overall Survival Rate(Up to 15 years)