NCT05768269招募中不适用
A Long-Term Follow-up Study for Subjects Previously Treated With A Century Therapeutics Cellular Therapy Product
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 7
- 主要终点
- Number of Participants With any Adverse Events of Special Interest (AESI)
研究概览
简要总结
This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.
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
- •Participant has provided written informed consent prior to any long-term follow-up (LTFU) study-specific procedures.
- •Participants received at least one treatment with a cellular therapy product in an eligible index trial.
- •Participant was withdrawn, early discontinued or completed an eligible index trial.
- •Participant is willing and able to comply with scheduled visits, study plan, and other study procedures.
排除标准
- •This study has no exclusion criteria.
结局指标
主要结局
Number of Participants With any Adverse Events of Special Interest (AESI)
时间窗: Up to 180 months
次要结局
- Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)(Up to 180 months)
- Overall Survival (OS)(From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months))
- Percentage of Participants With Persistent Product(Up to 180 months)
研究者
研究点 (7)
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