Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Overall Survival (OS) post-Infusion
研究概览
简要总结
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.
The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
详细描述
This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 who received an allogeneic, iPSC-derived NK cell in a Fate Therapeutics interventional study
- •Subjects who have provided Informed consent prior to their study participation
排除标准
- •Not Applicable
结局指标
主要结局
Overall Survival (OS) post-Infusion
时间窗: From the date of study entry until the date of documented death due to any cause, assessed up to 60 months.
OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause
次要结局
未报告次要终点