去中心化 CAR-T 生产：临床、经济与监管视角——世界血液与骨髓移植网络（WBMT）专题文章

Chimeric antigen receptor T-cell therapy transformed the treatment of hematologic malignancies and is rapidly expanding into solid tumors and autoimmune diseases. However, its full clinical potential remains constrained by centralized manufacturing, production costs, logistical complexity, prolonged vein-to-vein times, limited global accessibility, and regulatory frameworks that hinder rapid implementation of manufacturing innovations. Decentralized point-of-care manufacturing, pioneered by academic and clinical centers, offers a promising alternative to address these limitations and broaden patient access. This review summarizes the current landscape of POC CAR T-cell manufacturing, emphasizing clinical outcomes, economic sustainability, and regulatory considerations. Program experience across North America, Europe, Asia, and other regions demonstrates manufacturing innovations that reduce production times from several weeks to as few as 6-8 days. Early clinical studies report safety and efficacy comparable to commercially manufactured products while substantially lowering costs, with some models targeting production expenses of approximately USD 40,000 per treatment (excluding building and maintaining the production facility). We also examine supportive policy initiatives and regulatory pathways, including hospital exemption models, together with implementation challenges such as manufacturing heterogeneity, quality assurance, and workforce development. Finally, we discuss emerging technologies, including allogeneic CAR T-cell platforms, artificial intelligence-driven manufacturing, and in vivo gene editing, that may democratize global access.