工程化治疗性T细胞：从合成生物学到临床试验
Engineering Therapeutic T Cells: From Synthetic Biology to Clinical Trials.
作者信息
Esensten Jonathan H, Bluestone Jeffrey A, Lim Wendell A
机构信息
Department of Laboratory Medicine, University of California, San Francisco, California 94143; email:
Diabetes Center and Department of Medicine, University of California, San Francisco, California 94143; email:
出版信息
Annu Rev Pathol. 2017 Jan 24;12:305-330. doi: 10.1146/annurev-pathol-052016-100304. Epub 2016 Dec 5.
Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new technologies. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.
工程化T细胞目前正处于临床试验阶段，用于治疗癌症、实体器官移植和自身免疫性疾病患者。然而，该领域仍处于起步阶段。T细胞疗法的设计和制造尚未标准化，主要由相互竞争的团队在学术环境中进行。需要开发确定T细胞疗法剂量和药代动力学的可靠方法。截至2016年年中，市场上尚无美国食品药品监督管理局（FDA）批准的T细胞治疗药物，而且FDA的法规只是在缓慢地适应这些新技术。工程化T细胞疗法的进一步发展需要免疫学、合成生物学、制造工艺和政府监管等方面的进步。在本综述中，我们概述了其中的一些挑战，并讨论了病理学家对这一新兴领域可以做出的贡献。
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