Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
研究概览
简要总结
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors
详细描述
This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).
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 treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.
- •Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.
排除标准
- •Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.
研究组 & 干预措施
Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies
This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies.
Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product.
干预措施: Neoantigen specific TCR-T cell drug product (Biological)
结局指标
主要结局
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
时间窗: Up to 15 years post TCR-T cell drug product infusion
* Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies. * Incidence and duration of late onset adverse events * Proportion of subjects with adverse events leading to death * Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.
次要结局
- To investigate translational hypotheses related to TCR-T cell persistence.(Up to 15 years post TCR-T cell drug product infusion)
- To determine overall survival.(Up to 15 years post TCR-T cell drug product infusion)
- To continue the clinical efficacy assessment of TCR-T cell product.(Up to 15 years post TCR-T cell drug product infusion)