A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 5
- 主要终点
- Long-term safety of previous A2 Bio GT treatment
研究概览
简要总结
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
详细描述
This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study.
Participants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.
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
- •Received any amount of A2 Bio GT product on a previous A2 Bio interventional study
- •Able to provide written informed consent for this long-term follow-up study
- •Able to comply with study requirements
排除标准
- •1. There are no specific exclusion criteria for this study
研究组 & 干预措施
Participants that received A2 Bio GT products
干预措施: No additional intervention administered in this long term follow-up study (Other)
结局指标
主要结局
Long-term safety of previous A2 Bio GT treatment
时间窗: 15 years post treatment with A2 Bio GT product
Long-term safety of previous A2 Bio GT treatment as determined by incidence of adverse events (AEs)
次要结局
- Overall survival(15 years post treatment with A2 Bio GT product)
- Long-term durability of clinical effect of previous A2 Bio GT treatment(15 years post treatment with A2 Bio GT product)
- Progression Free Survival (PFS)(15 years post treatment with A2 Bio GT product)
- Incidence of RCL detected in blood(15 years post treatment with A2 Bio GT product)