Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies

Understanding regional distribution of HLA frequencies is crucial for optimizing enrollment in HLA-restricted clinical trials and to promote trial diversity per the Food and Drug Administration’s 2020 mandate. Using US HLA frequency data and census demographics we developed a method to create high-r...

Full description

Saved in:
Bibliographic Details
Main Authors: Dirk Nagorsen, Christian Roy, Tomasz Sewastianik, Ileana Saenz, Gregory J Opiteck, Sean Stagg, Martin Maiers
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/13/5/e011441.full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850033193621651456
author Dirk Nagorsen
Christian Roy
Tomasz Sewastianik
Ileana Saenz
Gregory J Opiteck
Sean Stagg
Martin Maiers
author_facet Dirk Nagorsen
Christian Roy
Tomasz Sewastianik
Ileana Saenz
Gregory J Opiteck
Sean Stagg
Martin Maiers
author_sort Dirk Nagorsen
collection DOAJ
description Understanding regional distribution of HLA frequencies is crucial for optimizing enrollment in HLA-restricted clinical trials and to promote trial diversity per the Food and Drug Administration’s 2020 mandate. Using US HLA frequency data and census demographics we developed a method to create high-resolution HLA class 1 genotypic frequency maps. Analyzing HLA-A*11:01 and HLA-B*58:01 as alleles of interest, we found significant US regional variations. HLA-A*11:01, which presents KRAS neoantigen mutations targeted by TCR T-cell therapies, showed 10–15% genotypic frequency (national average 11.2%), with western US states 1.5 times higher than average and local variations within California (10–19%). These insights can be used to guide clinical trial site selection, for example, in National Cancer Institute (NCI) cancer center catchment areas. For HLA-B*58:01, which reacts pharmacogenetically with allopurinol and results in severe cutaneous adverse reactions, Mississippi had a high frequency among US states, which could be used to guide potential public safety campaigns. This method can identify regions with high HLA type representation, aiding efficient patient identification and enrollment for HLA-specific clinical trials and health-awareness efforts.
format Article
id doaj-art-ad879b09aeba47578ebc2094d9a25aba
institution DOAJ
issn 2051-1426
language English
publishDate 2025-05-01
publisher BMJ Publishing Group
record_format Article
series Journal for ImmunoTherapy of Cancer
spelling doaj-art-ad879b09aeba47578ebc2094d9a25aba2025-08-20T02:58:18ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-05-0113510.1136/jitc-2024-011441Regional distribution of HLA frequencies in the USA: implications for TCR-based therapiesDirk Nagorsen0Christian Roy1Tomasz Sewastianik2Ileana Saenz3Gregory J Opiteck4Sean Stagg5Martin Maiers6Precision and Translational Medicine, Affini-T Therapeutics Inc, Watertown, Massachusetts, USAPrecision and Translational Medicine, Affini-T Therapeutics Inc, Watertown, Massachusetts, USAPrecision and Translational Medicine, Affini-T Therapeutics Inc, Watertown, Massachusetts, USAPrecision and Translational Medicine, Affini-T Therapeutics Inc, Watertown, Massachusetts, USAPrecision and Translational Medicine, Affini-T Therapeutics Inc, Watertown, Massachusetts, USANMDP, CIBMTR, Minneapolis, Minnesota, USANMDP, CIBMTR, Minneapolis, Minnesota, USAUnderstanding regional distribution of HLA frequencies is crucial for optimizing enrollment in HLA-restricted clinical trials and to promote trial diversity per the Food and Drug Administration’s 2020 mandate. Using US HLA frequency data and census demographics we developed a method to create high-resolution HLA class 1 genotypic frequency maps. Analyzing HLA-A*11:01 and HLA-B*58:01 as alleles of interest, we found significant US regional variations. HLA-A*11:01, which presents KRAS neoantigen mutations targeted by TCR T-cell therapies, showed 10–15% genotypic frequency (national average 11.2%), with western US states 1.5 times higher than average and local variations within California (10–19%). These insights can be used to guide clinical trial site selection, for example, in National Cancer Institute (NCI) cancer center catchment areas. For HLA-B*58:01, which reacts pharmacogenetically with allopurinol and results in severe cutaneous adverse reactions, Mississippi had a high frequency among US states, which could be used to guide potential public safety campaigns. This method can identify regions with high HLA type representation, aiding efficient patient identification and enrollment for HLA-specific clinical trials and health-awareness efforts.https://jitc.bmj.com/content/13/5/e011441.full
spellingShingle Dirk Nagorsen
Christian Roy
Tomasz Sewastianik
Ileana Saenz
Gregory J Opiteck
Sean Stagg
Martin Maiers
Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
Journal for ImmunoTherapy of Cancer
title Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
title_full Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
title_fullStr Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
title_full_unstemmed Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
title_short Regional distribution of HLA frequencies in the USA: implications for TCR-based therapies
title_sort regional distribution of hla frequencies in the usa implications for tcr based therapies
url https://jitc.bmj.com/content/13/5/e011441.full
work_keys_str_mv AT dirknagorsen regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT christianroy regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT tomaszsewastianik regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT ileanasaenz regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT gregoryjopiteck regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT seanstagg regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies
AT martinmaiers regionaldistributionofhlafrequenciesintheusaimplicationsfortcrbasedtherapies