Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
研究概览
简要总结
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
详细描述
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- •Patients must have provided informed consent for long-term follow-up study prior to participation.
- •Patients must be able to comply with the study requirements.
排除标准
- •There are no specific exclusion criteria for this study.
研究组 & 干预措施
AUTO CAR T cell therapy
Patients who received previous treatment with AUTO CAR T Cell Therapy
干预措施: AUTO CAR T cell therapy (Biological)
结局指标
主要结局
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
时间窗: For up to 15 years
Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.
次要结局
- Overall Survival following first AUTO CAR T cell therapy infusion.(Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15)
- Duration of response(Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15)
- Progression-free survival(Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15)
- Duration of supportive care(Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15)
- Testing for Insertional mutagenesis in case of a new malignancy(For up to 15 years)
- Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion(For up to 15 years)
- Proportion of patients with detectable vector copy number (VCN) in peripheral blood(Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15)