Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Overall Survival (OS) post-infusion
研究概览
简要总结
The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional 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.
For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.
详细描述
This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who received a Fate Therapeutics NK cell product that has been modified by lentivirus-mediated genetically engineering. The period of follow-up is 15 years after the administration of the NK cell product.
The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Fate Therapeutics clinical studies. Upon withdrawal or completion of the parent interventional study, the study site will contact the subject/healthcare provider/legal guardian annually.
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
- •Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study
排除标准
- •Not Applicable
结局指标
主要结局
Overall Survival (OS) post-infusion
时间窗: 15 years post last treatment
OS defined as the interval between the date of first Fate Therapeutics genetically modified NK cell product infusion and date of death due to any cause.
次要结局
- Incidence of LTFU adverse events (AEs), including serious adverse events (SAEs) associated with administration of Fate Therapeutics genetically modified NK cell product that have been genetically modified by lentiviral vectors.(15 years post last treatment)