Division of Hematology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy.
Department of Molecular Medicine, University of Pavia, Pavia, Italy.
Front Immunol. 2020 Oct 30;11:565236. doi: 10.3389/fimmu.2020.565236. eCollection 2020.
Chimeric Antigen Receptor-T cells (CAR-T) are considered novel biological agents, designed to selectively attack cancer cells expressing specific antigens, with demonstrated clinical activity in patients affected with relapsed/refractory B-cell malignancies. In consideration of their complexity, the use of CAR-T requires dedicated clinical setting and health care practitioners with expertise in the selection, treatment, and management of toxicities and side effects. Such issue appears particularly important when contextualized in the rapid progress of CAR-T cell treatment, translating into a constant need of updating and evolution. Moreover, the clinical grade manufacturing of CAR-T cells is complex and implies articulated regulatory and organizational aspects. The main goal of this review is to summarize and provide an accurate analysis of the clinical, logistic, and regulatory requirements of CAR-T cell centers. Finally, we describe a new occupational figure called "CAR-T specialist" devoted to the establishment and coordination of the required facilities and regulatory landscape in the context of cancer centers.
嵌合抗原受体 T 细胞（CAR-T）被认为是新型生物制剂，旨在选择性攻击表达特定抗原的癌细胞，在复发性/难治性 B 细胞恶性肿瘤患者中显示出临床活性。考虑到其复杂性，CAR-T 的使用需要专门的临床环境和具有选择、治疗和管理毒性和副作用专业知识的医疗保健从业者。当考虑到 CAR-T 细胞治疗的快速进展时，这种情况显得尤为重要，这意味着不断需要更新和发展。此外，CAR-T 细胞的临床级制造非常复杂，涉及到复杂的监管和组织方面。本篇综述的主要目的是总结和准确分析 CAR-T 细胞中心的临床、物流和监管要求。最后，我们描述了一种新的职业角色，称为“CAR-T 专家”，致力于在癌症中心建立和协调所需的设施和监管环境。
