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识别接受 CAR-T 治疗患者疗效和耐药的细胞及分子决定因素

英文原题:Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy

查看英文原题

Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy

ClinicalTrials.gov 2026/05/27(首次登记) 注册临床试验(分期未标注) · 招募中

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于恶性肿瘤、血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 700 例。试验地点:欧洲 · 里尔(共 2 个中心)。登记号:NCT07609485。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:男性或女性,年龄≥18岁,能够提供知情同意;任何适应症;接受市售CAR-T 治疗;任何预处理方案。排除标准:隐私自由(原登记文本如此表述);无医疗保险;接受非市售CAR-T 或其他CAR细胞治疗者。
核对登记原文(英文)
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.

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点治疗失败(疾病进展和复发)最长10年。
  • 次要终点对CAR-T 细胞及淋巴细胞亚群进行免疫表型分析,并对CAR-T 及相应肿瘤样本开展功能检测。
  • 次要终点对循环CAR-T 细胞及浸润肿瘤的CAR-T 细胞进行免疫表型分析和单细胞测序。
  • 次要终点测量血清细胞因子水平。
  • 次要终点建立生物样本库。
核对登记原文(英文)

主要终点:Treatment failure (progression and relapse) will be evaluated according to standard criteria · at 10 years
次要终点:Performing Immunophenotyping of CAR T cells and lymphocyte subsets as well as functional tests for CAR T and the corresponding tumor samples.;Performing Immunophenotyping and single cell sequencing of circulating CAR T cell and those infiltrating the tumor;Measurement of serum cytokine levels;constitution of a biological collection (biobank)

研究设计怎么做的

研究类型
观察性研究
入组人数
700 人(预计)

关键日期

开始日期
2021-02-18
主要完成日期
2028-02-18
全部完成日期
2028-02-18
登记状态核实于
2026-05

联系与责任方公示信息

申办方
University Hospital, Lille
联系电话
0320445962

以上邮箱 / 电话是登记库里的申办方联系方式(中国内地座机),通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。

登记简述

近年来,自体CAR-T 细胞治疗白血病和淋巴瘤取得突破,可使部分患者获得持久缓解。多项已批准的CAR-T 治疗试验(包括本中心试验)显示,在既往多线化疗或靶向治疗后疾病进展的患者中,约40%出现客观肿瘤消退。但并非所有患者均有应答,复发也较常见。因此,识别用于追踪CAR-T 临床活性及预测患者选择的生物标志物,对发展个体化细胞治疗至关重要。患者的应答程度和持续时间各不相同,提升持久缓解率是CAR-T 实现其治疗潜力的关键。疗效不仅取决于靶向恶性细胞常表达的抗原(如CD19、BCMA),也受输注CAR-T 细胞体内持续性差、迁移能力有限等因素制约。需要识别有利于CAR-T 细胞归巢至靶部位并长期存续、持续监视肿瘤的因素。目前,对于为何部分白血病和淋巴瘤患者在CAR-T 输注后获得完全且持久的抗肿瘤反应,而另一些患者仅部分应答后复发或完全无应答,认识仍不全面。确定促进CAR-T 细胞靶向归巢和长期持续的细胞及分子因素,有助于改进针对淋巴瘤及其他恶性肿瘤的CAR-T 治疗。

核对登记原文(英文)

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.

登记原文与核验信息

试验登记号
NCT07609485
试验状态
招募中
试验中心(2 个)
法国 2
适应症(原文)
Cancer; Hematologic Malignancy