Alsuliman Tamim, Drieu La Rochelle Laurianne, Campidelli Arnaud, Duléry Rémy, Fayard Amandine, Mamez Anne-Claire, Mear Jean-Baptiste, Schneider Pascale Odinet, Trevet Aurélie, Vicente Céline, Yakoub-Agha Ibrahim
AP-HP, hôpital Saint-Antoine, Sorbonne Université, 184, rue Faubourg-Saint-Antoine, 75012 Paris, France.
CHRU de Tours, 2, boulevard Tonnellé, 37000 Tours, France.
Bull Cancer. 2021 Dec;108(12S):S65-S71. doi: 10.1016/j.bulcan.2020.11.015. Epub 2021 Mar 4.
Chimeric antigen receptor (CAR) T cells are a new class of anti-cancer therapy that involves manipulating autologous or allogeneic T cells to express a CAR directed against a membrane antigen. In Europe, tisagenlecleucel (Kymriah™) has marketing authorization for the treatment of relapsed / refractory acute lymphoblastic leukemia (ALL) in children and young adults, in addition to the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL); the marketing authorization for axicabtagene ciloleucel (Yescarta™) is for the treatment of relapsed / refractory high-grade B-cell lymphoma and for the treatment of primary mediastinal B-cell lymphoma. Both cell products are genetically modified autologous T cells directed against CD19. These recommendations, drawn up by a working group of the Francophone Society of Bone Marrow transplantation and cellular Therapy (SFGM-TC) relate to the management of patients and the supply chain: medium-term complications, in particular cytopenias and B-cell aplasia, nursing and psychological supportive care. In another work, we will address long-term monitoring, post-marketing authorization pharmacovigilance and issues relating to JACIE and regulatory authorities. These recommendations are not prescriptive; their aim is to provide guidelines for the use of this new therapeutic approach. The purpose of this workshop is to outline the organizational aspects of this new therapeutic approach.
嵌合抗原受体(CAR)T细胞是一类新型抗癌疗法,涉及对自体或异体T细胞进行改造,使其表达针对膜抗原的嵌合抗原受体。在欧洲,tisagenlecleucel(Kymriah™)已获得上市许可,用于治疗儿童和年轻成人复发/难治性急性淋巴细胞白血病(ALL),以及复发/难治性弥漫性大B细胞淋巴瘤(DLBCL);axi-cabtagene ciloleucel(Yescarta™)的上市许可是用于治疗复发/难治性高级别B细胞淋巴瘤以及原发性纵隔B细胞淋巴瘤。这两种细胞产品均为针对CD19的基因改造自体T细胞。由法语国家骨髓移植和细胞治疗协会(SFGM-TC)的一个工作组制定的这些建议涉及患者管理和供应链:中期并发症,特别是血细胞减少症和B细胞发育不全、护理和心理支持护理。在另一项工作中,我们将讨论长期监测、上市后药物警戒以及与JACIE和监管机构相关的问题。这些建议并非强制性的;其目的是为这种新治疗方法的使用提供指导方针。本次研讨会的目的是概述这种新治疗方法的组织方面。