A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- The incidence of serious and non serious adverse events of special interest
研究概览
简要总结
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
详细描述
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
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
- •Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.
- •Provided written informed consent to participate in this study.
排除标准
- 未提供
研究组 & 干预措施
Long-term Follow-Up
No intervention
干预措施: Long-term Follow-Up (Other)
结局指标
主要结局
The incidence of serious and non serious adverse events of special interest
时间窗: Up to 15 years
AESIs will be collected
Number of subjects with related AEs, related SAEs, and all AESIs
时间窗: Up to 15 years
AESIs will be collected
Number of subjects with new or recurrence of pre-existing malignancy
时间窗: Up to 15 years
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder
时间窗: Up to 15 years
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders
时间窗: Up to 15 years
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders
时间窗: Up to 15 years
次要结局
- Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)(Up to 15 years)
- Objective response rate(Up to 15 years)
- Duration of zamtocabtagene autoleucel persistence(Up to 5 years)
- Overall Survival(Up to 15 years)
- Duration of zamtocabtagene autoleucel persistence(Up to 15 years)
- Objective Response Rate (ORR)(Up to 15 years)
- To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU(Up to 15 years)
- To assess immune reconstitution based on the recovery of total lymphocytes(Up to 15 years)