title: Engineering Therapeutic T Cells: From Synthetic Biology to Clinical Trials.
abstract: 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.
authors.affiliation: Department of Laboratory Medicine, University of California, San Francisco, California 94143; email: Jonathan.Esensten@ucsf.edu.
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Esensten
authors.affiliation: Diabetes Center and Department of Medicine, University of California, San Francisco, California 94143; email: Jeff.Bluestone@ucsf.edu.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Bluestone
authors.affiliation: Department of Cellular and Molecular Pharmacology, University of California, San Francisco 94158-2517; email: Wendell.Lim@ucsf.edu.
authors.forename: Wendell A
authors.initials: WA
authors.lastname: Lim
mesh_terms: D000818:Animals; D001327:Autoimmune Diseases / Q000276:immunology / Q000628:therapy*; D064987:Cell- and Tissue-Based Therapy; D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D058615:Synthetic Biology; D013601:T-Lymphocytes / Q000276:immunology*
keywords: T cells; cellular engineering; cellular therapy; immunotherapy; synthetic biology