接受转基因自体 T 细胞治疗的患者的长期随访
对先前接受过病毒载体基因修饰的自体 T 细胞治疗的患者进行长期随访
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Florida
-
Miami、Florida、美国、33136
- University of Miami
-
-
Missouri
-
St Louis、Missouri、美国、63110
- Washington University in St. Louis
-
-
Texas
-
Austin、Texas、美国、78704
- St David's South Austin Medical Center
-
-
-
-
-
Glasgow、英国
- Queen Elizabeth University Hospital
-
London、英国
- University College London Hospitals NHS Foundation Trust
-
Manchester、英国
- Royal Manchester Children's Hospital
-
Manchester、英国
- Manchester Royal Infirmary Hospital
-
Newcastle upon Tyne、英国
- Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
-
-
-
-
Catalonia
-
Barcelona、Catalonia、西班牙、08035
- Hospital Vall d'Hebron
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There are no specific exclusion criteria for this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AUTO CAR T cell therapy
Patients who received previous treatment with AUTO CAR T Cell Therapy |
No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
大体时间：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. |
For up to 15 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival following first AUTO CAR T cell therapy infusion.
大体时间：For up to 15 years
|
Overall Survival following first AUTO CAR T cell therapy infusion. |
For up to 15 years
|
|
Duration of supportive care
大体时间：For up to 15 years
|
B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy. |
For up to 15 years
|
|
Duration of response
大体时间：For up to 15 years
|
Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression. |
For up to 15 years
|
|
Progression-free survival
大体时间：For up to 15 years
|
Progression free survival following first AUTO CAR T cell therapy infusion. |
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
大体时间：For up to 15 years
|
Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion |
For up to 15 years
|
|
Proportion of patients with detectable vector copy number (VCN) in peripheral blood
大体时间：For up to 15 years
|
Blood sample collection for VCN measurement to detect persistence of CAR transgene(s) |
For up to 15 years
|
|
Testing for Insertional mutagenesis in case of a new malignancy
大体时间：For up to 15 years
|
Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy. |
For up to 15 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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