A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
研究概览
简要总结
This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.
Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.
Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.
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
- •All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
- •Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.
排除标准
- •Not applicable.
结局指标
主要结局
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
时间窗: Up to 15 years
Persistence of gene modified T cells
时间窗: Up to 15 years
Analysis of vector integration sites
时间窗: Up to 15 years
Incidence of RCL
时间窗: Up to 15 years
Disease progression status
时间窗: Up to 15 years
To assess long-term efficacy following treatment with gene modified T cells
Date of disease progression
时间窗: Up to 15 years
Survival status
时间窗: Up to 15 years
次要结局
- Health-Related Quality of Life (HRQoL) Changes(Up to 5 years)