A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 22
- 主要终点
- The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
研究概览
简要总结
This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
详细描述
All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.
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
- •Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document.
- •Must have received CRISPR CAR T cellular therapy.
排除标准
- •There are no specific exclusion criteria.
结局指标
主要结局
The incidence of adverse events, serious adverse events and adverse events of special interest related to CRISPR CAR T cellular therapy treatment.
时间窗: 15 years
The number and percentage of subjects with CRISPR CAR T cellular therapy related SAEs and AESIs will be summarized.
次要结局
- The overall survival and duration of remission/response following CRISPR CAR T cellular therapy treatment(15 years)