Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy (CAR-Lille)
2026年5月19日 更新者:University Hospital, Lille
Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy at the CHU, Lille: Biological Prospective Collection and Storage
In recent years we have witnessed a breakthrough in the treatment of leukemia and lymphoma using autologous CAR-T cells that can induce durable remission in patients.
Multiple approved CAR-T therapy trials, including those at our centre, have consistently yielded objective tumor regression rates in about 40% of patients that have progressed after multiple previous chemo or targeted therapies.
However, not all the patients respond to the therapy and rate of relapse is unfortunately common.
Hence, the identification of biomarkers to track clinical activity of CAR-T and as predictive tools for patient selection is critical in our quest to develop personalized cellular therapies, where both degree and duration of response varies among different patients.
For CAR-T therapy to truly live up to its promise, it is imperative to increase durable response rates.
The success of CAR-T therapy not only depends in targeting antigens (e.x.
CD19, BCMA) commonly expressed by malignant cells but also limited by poor persistence and trafficking of infused CAR-T cells in vivo.
Hence highlighting the need to identify factors that exhibit optimal homing to the target sites and are able to persist long-term for continuous tumor surveillance.
Furthermore, we lack comprehensive knowledge on how certain patients with leukemia and lymphoma achieve complete durable anti-cancer response upon CAR-T infusion whereas other either partially respond to the therapy and then relapse, or do not respond at all.
Determining cellular and molecular factors that contribute to optimal homing of CAR-T cell to target sites as well as their long-term persistence will help us to design improved CAR-T based therapy against lymphoma other malignancies.
研究概览
研究类型
观察性的
注册 (估计的)
700
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Ibrahim Yakoub-Agha, MD,PhD
- 电话号码:+33 0320445962
- 邮箱:ibrahim.yakoubagha@chru-lille.fr
学习地点
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Lille、法国
- 招聘中
- CHU de Lille
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接触:
- ibrahim Yakoub-Agha
- 电话号码:+33(0)3.20.44.55.51
- 邮箱:ibrahim.yakoubagha@chru-lille.fr
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Lille、法国、59037
- 终止
- Hop Claude Huriez Chu Lille
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
Samples from eligible patients who receives commercially available CAR-T therapy will be collected and stored at regular intervals
描述
Inclusion Criteria:
- Male or female aged ≥ 18 years and able to provide informed consent
- Any indication,
- Commercially available CART therapies,
- Any conditioning.
Exclusion Criteria:
- Freedom privacy
- Absence of medical coverage
- Patients receiving CART or CAR-based cellular therapies which are not commercially available.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Treatment failure (progression and relapse) will be evaluated according to standard criteria
大体时间:at 10 years
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at 10 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Performing Immunophenotyping of CAR T cells and lymphocyte subsets as well as functional tests for CAR T and the corresponding tumor samples.
大体时间:at 10 years
|
at 10 years
|
|
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Performing Immunophenotyping and single cell sequencing of circulating CAR T cell and those infiltrating the tumor
大体时间:at 10 years
|
at 10 years
|
|
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Measurement of serum cytokine levels
大体时间:at 10 years
|
at 10 years
|
|
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constitution of a biological collection (biobank)
大体时间:at 10 years
|
Tests are done as needed (Immunophenotyping, DNA sequencing, cytokine measurement,..)
|
at 10 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ibrahim Yakoub-Agha, MD,PhD、University Hospital, Lille
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年2月18日
初级完成 (估计的)
2028年2月18日
研究完成 (估计的)
2028年2月18日
研究注册日期
首次提交
2020年12月2日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.