Chabannon Christian, Larghero Jérôme
Institut Paoli-Calmettes, Centre de Thérapie Cellulaire & Inserm CBT-1409, Centre d'Investigations Cliniques en Biothérapies de Marseille, 13009 Marseille, France.
AP-HP, Hôpital Saint-Louis, Unité de Thérapie Cellulaire & Inserm CBT-501, Centre d'Investigations Cliniques en Biothérapies, 75010 Paris, France.
Bull Cancer. 2018 Dec;105 Suppl 2:S198-S204. doi: 10.1016/S0007-4551(19)30050-5.
HOW CAN FRENCH HEALTHCARE PROVIDERS ADAPT THEIR ORGANIZATION TO REQUIREMENTS FOR MANUFACTURING AND DELIVERY OF THESE INNOVATIVE CELL-BASED MEDICINAL PRODUCTS?: More than five years after the first US publications reporting a significant rate of clinical responses in patients with high-risk or advanced CD19+ lymphoid malignancies, access to treatment with CAR-T Cells at European hospitals in general and at French hospitals in particular remains limited. One - and not the least - hurdle lay in the need to set up a complex and unprecedented organization that complies with European regulations on Advanced Therapy Medicinal Products as well as with national (French) regulations. We here review the organizational framework for two situations: delivery and administration of industry-manufactured CAR-T Cells as well as engineering and distribution of CAR-T Cells produced as investigational drugs to be evaluated in the context of clinical research protocols. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene.
法国医疗服务提供者如何调整其组织以适应这些基于细胞的创新药品的生产和交付要求?:在美国首次发表关于高危或晚期CD19+淋巴恶性肿瘤患者临床缓解率显著的报告五年多后,欧洲医院,尤其是法国医院,使用CAR-T细胞进行治疗的机会仍然有限。其中一个——而且是相当大的——障碍在于需要建立一个复杂且前所未有的组织,该组织既要符合欧洲关于高级治疗药品的法规,也要符合国家(法国)法规。我们在此回顾两种情况的组织框架:工业生产的CAR-T细胞的交付和管理,以及作为研究药物生产的CAR-T细胞在临床研究方案背景下进行评估时所涉及的工程和分发。本文是在吉利德合作伙伴Kite和新基的机构支持下制作的增刊《CAR-T细胞:一场治疗革命?》的一部分。