NCT06925685Enrolling By Invitation不适用
Long Term Follow up Study for Participants Treated With an Allogeneic CAR T-Cell Product in a Prior Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs
研究概览
简要总结
An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study
排除标准
- •Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor
结局指标
主要结局
Incidence of delayed adverse events potentially related to allogeneic CAR T-cell product and allogeneic CAR T-cell product-related SAEs
时间窗: Up to 15 years post treatment with allogeneic CAR T-cell product
Overall survival (OS)
时间窗: Up to 15 years post treatment with allogeneic CAR T cell product
Presence of replication competent lentivirus (RCL) in blood
时间窗: Up to 15 years post treatment with allogeneic CAR T cell product
次要结局
未报告次要终点
研究者
研究点 (1)
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