title: Considerations for the clinical application of chimeric antigen receptor T cells: observations from a recombinant DNA Advisory Committee Symposium held June 15, 2010.
abstract: T cells that are genetically modified to express single-chain chimeric antigen receptors (CAR) have shown promise in early cancer immunotherapy clinical trials. Unfortunately, 2 recent deaths in cancer patients treated with CAR T cells have created some uncertainty on how to best mitigate patient risk, while continuing to advance this very promising therapeutic avenue. In order to address these concerns, the Recombinant DNA Advisory Committee (RAC) held a symposium, the objectives of which were to first review the reported treatment-associated toxicities and, second, to discuss methods for improving safety and efficacy. This report highlights the issues raised as part of this discussion, with a specific focus on protocols infusing CAR T cells. Because this was not a consensus conference, the opinions described should not be construed to represent those of any individual RAC member, the RAC as a body, conference participants, the National Institutes of Health, or the U.S. Food and Drug Administration.
authors.affiliation: Wistar Institute, USA.
authors.forename: Hildegund C J
authors.initials: HC
authors.lastname: Ertl
authors.forename: John
authors.initials: J
authors.lastname: Zaia
authors.forename: Steven A
authors.initials: SA
authors.lastname: Rosenberg
authors.forename: Carl H
authors.initials: CH
authors.lastname: June
authors.forename: Gianpietro
authors.initials: G
authors.lastname: Dotti
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Kahn
authors.forename: Laurence J N
authors.initials: LJ
authors.lastname: Cooper
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Corrigan-Curay
authors.forename: Scott E
authors.initials: SE
authors.lastname: Strome
mesh_terms: D006801:Humans; D016219:Immunotherapy, Adoptive / Q000379:methods*; D009369:Neoplasms / Q000276:immunology / Q000628:therapy; D011948:Receptors, Antigen, T-Cell / Q000008:administration & dosage* / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology; D013601:T-Lymphocytes / Q000276:immunology*
chemical_list: D011948:Receptors, Antigen, T-Cell; D011993:Recombinant Fusion Proteins