A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics

Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on...

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Veröffentlicht in:Nature reviews. Drug discovery 2024-01, Vol.23 (1), p.1-2
Hauptverfasser: Meyer, Miriam, Mahr, Andrea, Brewer, Joanna, Daniel, Volker, Dell‘Aringa, Justine, Goldstone, Tony, Hersey, Sarah, Johnston, Ian, Larson, Pamela, Loveridge, Michael, MacBeath, Gavin, Moyer, Mark, Nagorsen, Dirk, Papa, Sophie, Peiser, Leanne, Ranade, Koustubh, Rizzi, Ruben, Roers, Axel, Schendel, Dolores, Sivakumar, Pallavur, Tran, Eric, Türeci, Özlem, Weigand, Luise, Wennborg, Anders, Williams, Dennis, Yee, Cassian, Britten, Cedrik M.
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container_issue 1
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container_title Nature reviews. Drug discovery
container_volume 23
creator Meyer, Miriam
Mahr, Andrea
Brewer, Joanna
Daniel, Volker
Dell‘Aringa, Justine
Goldstone, Tony
Hersey, Sarah
Johnston, Ian
Larson, Pamela
Loveridge, Michael
MacBeath, Gavin
Moyer, Mark
Nagorsen, Dirk
Papa, Sophie
Peiser, Leanne
Ranade, Koustubh
Rizzi, Ruben
Roers, Axel
Schendel, Dolores
Sivakumar, Pallavur
Tran, Eric
Türeci, Özlem
Weigand, Luise
Wennborg, Anders
Williams, Dennis
Yee, Cassian
Britten, Cedrik M.
description Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on patients and the organizations developing these products. We propose regulatory flexibility to facilitate the development of and access to TCR-based therapeutics. Current regulation of T cell receptor (TCR)-based therapeutics may require repeated testing of patients for specific HLA alleles as well as companion diagnostics development, despite the invariant nature of the HLA genotype and availability of robust clinical HLA tests. This increases the burden on patients and the organizations developing these products. We propose regulatory flexibility to facilitate the development of and access to TCR-based therapeutics.
doi_str_mv 10.1038/d41573-023-00189-4
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subjects Biomedicine
Biotechnology
Cancer Research
Comment
Histocompatibility Testing
Humans
Immunotherapy - standards
Medicinal Chemistry
Molecular Medicine
Pharmacology/Toxicology
Receptors, Antigen, T-Cell
title A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics
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