Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Hematologic Malignancies and Bone Marrow Transplantation Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Division of Clinical Research, Fred Hutchinson Cancer Research Center and Department of Medicine, University of Washington, Seattle, Washington.
Biol Blood Marrow Transplant. 2019 Dec;25(12):2305-2321. doi: 10.1016/j.bbmt.2019.08.015. Epub 2019 Aug 22.
Axicabtagene ciloleucel (YESCARTA; Kite Pharma, a Gilead Company, Los Angeles CA) and tisagenlecleucel (KYMRIAH; Novartis Pharmaceuticals Corp., Basel, Switzerland) are two CD19-directed chimeric antigen receptor (CAR) T cell products currently approved by the US Food and Drug Administration; the European Medicines Agency; Health Canada; Ministry of Health, Labor and Welfare (Japan); and Therapeutic Goods Administration (Australia) for treatment of specific subtypes of relapsed/refractory aggressive B cell non-Hodgkin lymphoma (NHL). Although this approval has been transformative in the use of cellular immunotherapy in lymphoma, there are concerns regarding appropriate use of this novel therapy and of short- and long-term toxicities. To address these issues, representatives of the American Society of Transplantation and Cellular Therapy convened to recognize and address key issues surrounding the clinical application of CD19 CAR T cell therapy in B cell lymphomas, in collaboration with worldwide experts. The aim of this article is to provide consensus opinion from experts in the fields of hematopoietic cell transplantation, cellular immunotherapy, and lymphoma regarding key clinical questions pertinent to the use of CD19 CAR T cell products for the treatment of NHL. As the clinical practice using CAR T cells grows worldwide, we anticipate that this guidance will be relevant for hematology/oncology physicians who care for patients with lymphomas.
阿基卡宾塔吉奥赛卡(Axicabtagene ciloleucel,Yescarta;Kite Pharma,加利福尼亚州洛杉矶的吉利德公司)和替西奥塞卡(Tisagenlecleucel,Kymriah;诺华制药公司,瑞士巴塞尔)是两种 CD19 导向嵌合抗原受体(CAR)T 细胞产品,目前已获得美国食品和药物管理局、欧洲药品管理局、加拿大卫生部、日本厚生劳动省和澳大利亚治疗用品管理局批准,用于治疗特定亚型的复发/难治性侵袭性 B 细胞非霍奇金淋巴瘤(NHL)。尽管这一批准改变了淋巴瘤细胞免疫治疗的应用方式,但人们对这种新型治疗方法的合理应用以及短期和长期毒性仍存在担忧。为了解决这些问题,美国移植和细胞治疗学会的代表与全球专家合作,召集了一次会议,以认识和解决与 CD19 CAR T 细胞疗法在 B 细胞淋巴瘤临床应用相关的关键问题。本文的目的是为造血细胞移植、细胞免疫治疗和淋巴瘤领域的专家提供关于使用 CD19 CAR T 细胞产品治疗 NHL 的关键临床问题的共识意见。随着全球使用 CAR T 细胞治疗的临床实践不断发展,我们预计本指南将与关注淋巴瘤患者的血液科/肿瘤学家相关。