A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 546
- 试验地点
- 11
- 主要终点
- Percentage of participants with targeted adverse events (AEs)
研究概览
简要总结
This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit/risk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
排除标准
- •There are no exclusion criteria for this study
研究组 & 干预措施
Previously treated participants with GLPG CAR T-cell therapy
All participants who have been treated with a Galapagos CAR T-cell therapy
干预措施: GLPG CAR T-cell therapy (Genetic)
结局指标
主要结局
Percentage of participants with targeted adverse events (AEs)
时间窗: From infusion up to 15 years
Percentage of participants with detectable CAR transgene levels in peripheral blood
时间窗: From infusion up to 15 years
Percentage of participants with serious AEs (SAEs) considered related to the Galapagos CAR T-cell therapy
时间窗: From infusion up to 15 years
Percentage of participants with at least 1% of T-cells in the blood sample or positive new malignancies
时间窗: From infusion up to 15 years
Percentage of participants with detectable replication-competent lentivirus (RCL) in peripheral blood
时间窗: From infusion up to 15 years
Percentage of participants who died with causes
时间窗: From infusion up to 15 years
次要结局
- Percentage of participants with disease progression(From infusion up to 15 years)
- Time to subsequent anticancer therapy(From infusion up to 15 years)
- Overall survival(From infusion up to 15 years)