Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 16
- 主要终点
- Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
研究概览
简要总结
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
时间窗: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
时间窗: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by overall survival
时间窗: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product
时间窗: Total of 15 years after first receiving an ACTR T cell product
ACTR T cell persistence in subjects previously treated with an ACTR T cell product
时间窗: Total of 15 years after first receiving an ACTR T cell product
次要结局
未报告次要终点