使用嵌合抗原受体(CAR)T细胞的过继性细胞免疫疗法已成为治疗复发性和/或难治性B细胞非霍奇金淋巴瘤(B-NHL)的新方法。随着越来越多的CART细胞产品的批准和CART细胞疗法的进步,预计CART细胞将用于越来越多的病例。然而,CAR-T细胞相关的毒性可能是严重的,甚至是致命的。从而损害了这种疗法的生存益处。规范和研究这些毒性的临床管理势在必行。与其他血液恶性肿瘤相比,如急性淋巴细胞白血病和多发性骨髓瘤,抗CD19CART细胞相关毒性在B-NHL有几个独特的特征,最值得注意的是局部细胞因子释放综合征(CRS)。然而,先前发布的指南对CAR-T细胞治疗B-NHL相关毒性的分级和管理提供了很少的具体建议.因此,我们达成了预防的共识,认可,以及这些毒性的管理,根据已发表的有关抗CD19CART细胞相关毒性管理的文献和多个中国机构的临床经验。该共识完善了B-NHL中CRS的分级体系和分类以及CRS管理的相应措施,并描述了除CRS外,管理抗CD19CART细胞相关毒性的综合原则和探索性建议。
Adoptive cellular immunotherapy with chimeric antigen receptor (CAR) T cells has emerged as a novel modality for treating relapsed and/or refractory B-cell non-Hodgkin lymphoma (B-NHL). With increasing approval of CAR T-cell products and advances in CAR T cell therapy, CAR T cells are expected to be used in a growing number of cases. However, CAR T-cell-associated toxicities can be severe or even fatal, thus compromising the survival benefit from this therapy. Standardizing and studying the clinical management of these toxicities are imperative. In contrast to other hematological malignancies, such as acute lymphoblastic leukemia and multiple myeloma, anti-CD19 CAR T-cell-associated toxicities in B-NHL have several distinctive features, most notably local cytokine-release syndrome (CRS). However, previously published
guidelines have provided few specific recommendations for the grading and management of toxicities associated with CAR T-cell treatment for B-NHL. Consequently, we developed this
consensus for the prevention, recognition, and management of these toxicities, on the basis of published literature regarding the management of anti-CD19 CAR T-cell-associated toxicities and the clinical experience of multiple Chinese institutions. This
consensus refines a grading system and classification of CRS in B-NHL and corresponding measures for CRS management, and delineates comprehensive principles and exploratory recommendations for managing anti-CD19 CAR T-cell-associated toxicities in addition to CRS.