A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of specific AEs
研究概览
简要总结
Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.
详细描述
This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has received a cell or gene therapy in another AstraZeneca protocol.
- •Provision of signed and dated, written informed consent before any study-specific procedures.
排除标准
- •Not applicable
研究组 & 干预措施
AZD5851
Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884
干预措施: AZD5851 (Biological)
AZD0754
Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729
干预措施: AZD0754 (Biological)
结局指标
主要结局
Incidence of specific AEs
时间窗: Maximum of 15 years post dosing
To determine long-term safety of previous treatment with applicable cell and gene therapy products
次要结局
- Disease progression status and Overall survival(Maximum of 15 years post dosing.)
- Kinetics parameters that indicate persistence (eg, Clast and Tlast)(Maximum of 15 years post dosing)