Chimeric antigen receptor (CAR)-T cell therapies have improved the outcome for many patients with relapsed or refractory aggressive B-cell lymphomas. In 2017, axicabtagene ciloleucel and soon after tisagenlecleucel became the first approved CAR-T cell products for patients with high-grade B-cell lymphomas or diffuse large B-cell lymphoma (DLBCL) who are relapsed or refractory to ≥ 2 prior lines of therapy; lisocabtagene maraleucel was approved in 2021. Safety and efficacy outcomes from the pivotal trials of each CAR-T cell therapy have been reported. Despite addressing a common unmet need in the large B-cell lymphoma population and utilizing similar CAR technologies, there are differences between CAR-T cell products in manufacturing, pivotal clinical trial designs, and data reporting. Early reports of commercial use of axicabtagene ciloleucel and tisagenlecleucel provide the first opportunities to validate the impact of patient characteristics on the efficacy and safety of these CAR-T cell therapies in the real world. Going forward, caring for patients after CAR-T cell therapy will require strategies to monitor patients for sustained responses and potential long-term side effects. In this review, product attributes, protocol designs, and clinical outcomes of the key clinical trials are presented. We discuss recent data on patient characteristics, efficacy, and safety of patients treated with axicabtagene ciloleucel or tisagenlecleucel in the real world. Finally, we discuss postinfusion management and preview upcoming clinical trials of CAR-T cell therapies.

中文翻译：

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以 CD19 为导向的 CAR-T 细胞疗法在复发/难治性侵袭性 B 细胞淋巴瘤患者中的疗效和安全性：来自 JULIET、ZUMA-1 和 TRANSCEND 试验的观察结果

嵌合抗原受体 (CAR)-T 细胞疗法改善了许多复发性或难治性侵袭性 B 细胞淋巴瘤患者的预后。2017 年，axicabtagene ciloleucel 和 tisagenlecleucel 成为第一个获批的 CAR-T 细胞产品，用于治疗复发或对 ≥ 2 种先前治疗线无效的高级别 B 细胞淋巴瘤或弥漫性大 B 细胞淋巴瘤 (DLBCL) 患者; Lisocabtagene maraleucel 于 2021 年获得批准。每种 CAR-T 细胞疗法的关键试验的安全性和有效性结果均已报告。尽管解决了大型 B 细胞淋巴瘤群体中普遍未满足的需求并利用了类似的 CAR 技术，但 CAR-T 细胞产品在制造、关键临床试验设计和数据报告方面存在差异。关于 axicabtagene ciloleucel 和 tisagenlecleucel 商业用途的早期报道提供了第一个机会来验证患者特征对现实世界中这些 CAR-T 细胞疗法的功效和安全性的影响。展望未来，在 CAR-T 细胞治疗后照顾患者将需要监测患者的持续反应和潜在的长期副作用的策略。在这篇综述中，介绍了关键临床试验的产品属性、方案设计和临床结果。我们讨论了在现实世界中使用 axicabtagene ciloleucel 或 tisagenlecleucel 治疗的患者的患者特征、疗效和安全性的最新数据。最后，我们讨论了输注后管理并预览了即将进行的 CAR-T 细胞疗法临床试验。