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Development and Use of the Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy Axicabtagene Ciloleucel in Large B-Cell Lymphoma: A Review.
Anti-CD19 嵌合抗原受体 T 细胞治疗大 b细胞淋巴瘤的开发和使用: 综述。

摘要

Importance:Axicabtagene ciloleucel, an anti-CD19-CD28-CD3ζ chimeric antigen receptor T-cell therapy, was the first US Food and Drug Administration-approved, genetically engineered T-cell therapy for adults with relapsed or refractory large B-cell lymphoma (LBCL) after 2 or more lines of systemic therapy. There has not been a US Food and Drug Administration-approved product for these cancers in more than 4 decades.
Observations:Unlike traditional anticancer therapies, axicabtagene ciloleucel is a patient-specific, live-cell product that has unique requirements for manufacturing, shipping, and storage, as well as for its administration and management of its adverse events. In addition, axicabtagene ciloleucel has demonstrated efficacy in patients with refractory LBCL. This review presents a timeline of the rapid clinical development of axicabtagene ciloleucel from bench to bedside, highlights how axicabtagene ciloleucel satisfies an unmet medical need for treatment of refractory LBCL, outlines the logistics of the production process and administration of axicabtagene ciloleucel, describes its mechanism of action, and summarizes the results of the pivotal study. This review also provides a survey of adverse events, with attention to the kinetics of their clinical presentation; discusses the management of adverse events; and offers suggestions for appropriate patient selection for safe administration of axicabtagene ciloleucel.
Conclusions and Relevance:The integration of axicabtagene ciloleucel therapy into standard-of-care practice for relapsed/refractory LBCL is the beginning of a paradigm shift in the treatment of patients with LBCL and is likely to lead to improvements in their survival and curability. Timely referral to centers offering the therapy is necessary for optimal patient outcomes.

译文

重要性: Axicabtagene ciloleucel,一种 anti-CD19-CD28-CD3 zeta 嵌合抗原受体 T 细胞疗法,是第一个美国食品和药物管理局批准的, 基因工程 T 细胞治疗成人复发或难治性大 b细胞淋巴瘤 (LBCL),经过 2 行或更多行全身治疗。40 多年来,美国食品和药物管理局还没有批准的治疗这些癌症的产品。
观察: 与传统抗癌疗法不同,axicabtagene ciloleucel 是一种患者特异性的活细胞产品,对制造、运输和储存有独特的要求, 以及对其不良事件的管理。此外,axicabtagene ciloleucel 已在难治性 LBCL 患者中显示出疗效。这篇综述展示了从工作台到床边的 axicabtagene ciloleucel 快速临床发展的时间表,强调了 axicabtagene ciloleucel 如何满足治疗难治性 LBCL 的未满足的医疗需求, 概述了 axicabtagene ciloleucel 的生产过程和管理的物流,描述了其作用机制,并总结了关键研究结果。该综述也提供了一个不良事件的调查,关注其临床表现的动力学; 讨论了不良事件的管理; 并为适当的患者选择提供了安全给药的建议。
结论和相关性: 将 axicabtagene ciloleucel 疗法纳入复发/难治性 LBCL 的标准治疗实践是 LBCL 患者治疗范式转变的开始,并可能导致改善他们的生存和治愈能力。及时转诊到提供治疗的中心对于最佳患者结果是必要的。

Chimeric Antigen Receptor T-Cell

肿瘤 免疫治疗 临床研究术语
概述  :  

CAR-T是一种新型的肿瘤免疫治疗方法。该治疗方法是将外源构建的能够识别某种肿瘤抗原的抗原结合部(一般为单链抗体,ScFv)与CD3ζ链及某些T细胞共刺激因子的胞内信号组合的嵌合蛋白,通过基因转导的方法转染患者T细胞,使其表达嵌合抗原受体分子(CAR)。重编程后的T细胞为CAR-T细胞,能够特异识别其靶向的肿瘤抗原,并对肿瘤发挥杀伤作用。 原理CAR分子结构主要包含3个部分。第一部分为胞外抗原识别域,根据所需要识别的肿瘤靶点,其通常为一个(或多个)单链抗体,也可以是多肽或者其他蛋白

Chimeric   /kaɪ'mɛrɪk/ 

       adj.妄想的;荒诞不经的 [医]嵌合的,嵌合体的

同根词   chimerical adj.空想的,妄想的,荒唐的;chimera n.嵌合体,虚构的怪物,妄想

       And, the immune system does not stay chimeric forever.  此外,这种免疫系统并不会永远保持嵌合状态。

 

Antigen   英 /'æntɪdʒ(ə)n/   美 /'æntɪdʒən/ 

    义   n. [免疫]抗原

       The attraction between an antigen and an antibody.  化合力抗原和抗体之间的相互吸引。

    

Receptor   英 /rɪ'septə/   美 /rɪ'sɛptɚ/ 

释    义   [生化]受体;接收器;感觉器官

       Human tumor cells expressed high levels of growth factor and its receptor.  人类肿瘤细胞表达高水平的生长因子及其受体。

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