重组抗体（Abs）是治疗多种肿瘤恶性肿瘤的不可或缺的方式。自从美国食品和药物管理局 (FDA) 批准利妥昔单抗作为第一种用于癌症治疗的单克隆抗体 (mAb) 以来，多种单克隆抗体和基于抗体 (Ab) 的疗法已被批准用于治疗实体瘤恶性肿瘤和其他癌症。这些抗体通过阻断致癌途径或血管生成、调节免疫反应或通过递送结合药物来发挥作用。然而，在可以从治疗中受益的癌症患者中使用基于抗体的疗法仍然受到相关毒性特征的限制，这些毒性特征可能源于与靶标结合相关的生物学特征和过程，以及治疗性抗体的生化和/或生物物理特征。与基于抗体的疗法相关的一个重要的免疫相关不良事件 (irAE) 是细胞因子释放综合征 (CRS)，其特征是出现发烧、皮疹，甚至出现明显的危及生命的低血压，以及继发于全身不受控制的增加的急性炎症一系列促炎细胞因子。在这里，我们回顾了与特定类别的已批准的基于抗体的新型癌症免疫疗法相关的 irAE，即免疫检查点 (IC) 靶向抗体、双特异性抗体 (BsAb) 和抗体药物偶联物 (ADC)，强调了协调一致的重要性用于基于抗体的生物治疗药物安全性评估的临床前测定开发，作为支持和完善临床翻译的方法。© 2024 Crown 版权所有。细胞与分子医学基金会和约翰·威利出版的《细胞与分子医学杂志》

Recombinant antibodies (Abs) are an integral modality for the treatment of multiple tumour malignancies. Since the Food and Drug Administration (FDA) approval of rituximab as the first monoclonal antibody (mAb) for cancer treatment, several mAbs and antibody (Ab)-based therapies have been approved for the treatment of solid tumour malignancies and other cancers. These Abs function by either blocking oncogenic pathways or angiogenesis, modulating immune response, or by delivering a conjugated drug. The use of Ab-based therapy in cancer patients who could benefit from the treatment, however, is still limited by associated toxicity profiles which may stem from biological features and processes related to target binding, alongside biochemical and/or biophysical characteristics of the therapeutic Ab. A significant immune-related adverse event (irAE) associated with Ab-based therapies is cytokine release syndrome (CRS), characterized by the development of fever, rash and even marked, life-threatening hypotension, and acute inflammation with secondary to systemic uncontrolled increase in a range of pro-inflammatory cytokines. Here, we review irAEs associated with specific classes of approved, Ab-based novel cancer immunotherapeutics, namely immune checkpoint (IC)-targeting Abs, bispecific Abs (BsAbs) and Ab-drug-conjugates (ADCs), highlighting the significance of harmonization in preclinical assay development for safety assessment of Ab-based biotherapeutics as an approach to support and refine clinical translation.© 2024 Crown copyright. Journal of Cellular and Molecular Medicine published by Foundation for Cellular and Molecular Medicine and John Wiley & Sons Ltd. This article is published with the permission of the Controller of HMSO and the King's Printer for Scotland.