A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1/2 Study and Treated With ARD103 CAR-T Cell Therapies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
研究概览
简要总结
This study will evaluate the long-term safety of ARD103 cellular therapies
详细描述
Participants who receive administration of ARD103 (i.e., a partial dose or a full dose) will roll into the LTFU study upon completion of the 24-month interventional study period (Study: ARD103_ARCE-CL-P-001), or after early discontinuation from the interventional study protocol. The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration. Participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the LTFU study. No IP will be administered during the LTFU study. The number and percentage of participants with ARD103 CAR-T cell therapy related AEs, SAEs, and AESIs will be recorded throughout the LTFU Period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
- •The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.
排除标准
- •There are no specific exclusion criteria for this study
结局指标
主要结局
The incidence and duration of AEs, SAEs, and AESIs related to ARD103 treatment.
时间窗: 15 years
The number and percentages of participants experiencing TEAEs will be tabulated. Serious TEAEs will be summarized and AESIs will be summarized.
次要结局
- The long-term efficacy of ARD103 in participants with R/R AML or MDS(15 years)