A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Wugen, Inc.
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Delayed adverse events (AEs)/serious adverse events (SAEs)
研究概览
简要总结
This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.
详细描述
This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.
Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.
Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.
排除标准
- •Not Applicable
结局指标
主要结局
Delayed adverse events (AEs)/serious adverse events (SAEs)
时间窗: up to 15 years
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
Persistence of WU-CART-007 cells
时间窗: Every 6 months for up to 5 years and then yearly for up to 15 years
Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
Tanner Staging
时间窗: up to 15 years
Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were \< 18 years of age at the time of treatment with WU CART-007
次要结局
- Overall survival (OS)(up to 15 years)
- Progression-free survival (PFS)(up to 15 years)