Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 6
- 主要终点
- To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.
研究概览
简要总结
This is a multicenter, open-label, single-arm, long-term follow-up clinical study. All patients who have received Equecabtagene Autoleucel Injection treatment will be enrolled.
详细描述
The main follow-up period for pre-marketing clinical studies related to Equecabtagene Autoleucel Injection is 2 years. The "Technical Guidelines for Long-term Follow-up Clinical Studies of Gene Therapy Products (Trial)" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) recommends a follow-up period of not less than 15 years for gene therapy products with genomic integration activity.
In order to observe the long-term safety and efficacy of Equecabtagene Autoleucel Injection, as well as the persistence of CAR-T cells in vivo, and to identify whether there are differences in safety among populations with different indications, this study will conduct long-term follow-up in patients treated with Equecabtagene Autoleucel Injection, thereby identifying long-term risks and helping to evaluate the product's benefit-risk profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Received Equecabtagene Autoleucel Injection treatment; 2.For those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.
排除标准
- •Receipt of another lentiviral vector-based cell or gene therapy (either commercialized product or investigational product in a clinical tiral) between the infution of Equecabtagene Autoleucel Injection and the signing informed consent.
结局指标
主要结局
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.
时间窗: Up to 15 years from enrollment
次要结局
未报告次要终点