A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Number of subjects with adverse events as assessed by CTCAE v5.0.
研究概览
简要总结
The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.
Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.
详细描述
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects who received at least one CLBR001 cell dose.
排除标准
- 未提供
研究组 & 干预措施
CLBR001 Treated Subjects
Subjects who received CLBR001 on any Calibr treatment study.
干预措施: Long Term Follow-Up (Other)
结局指标
主要结局
Number of subjects with adverse events as assessed by CTCAE v5.0.
时间窗: To 15 years post-CLBR001 administration.
To assess the long term safety of CLBR001 in subjects by evaluating the incidence, duration, and outcome of adverse events (including adverse events of special interest, CLBR001-related adverse events and serious adverse events), as assessed by CTCAE v5.0.
Number of subjects with replication competent lentivirus (RCL).
时间窗: To 15 years post-CLBR001 administration.
To assess the long term safety of CLBR001 in subjects by evaluating the proportion of subjects with detectable RCL from CLBR001.
次要结局
未报告次要终点