Abstract C100: Geospatial access to CAR-T clinical trials for non-Hodgkin lymphoma in the United States: Are persons with HIV included?

Abstract Introduction: Chimeric antigen receptor T-cell (CAR-T) therapy is a paradigm-changing therapy in the treatment of non-Hodgkin Lymphoma (NHL). While NHL is the leading cause of cancer-related death for persons living with HIV (PWH) in high-income countries, PWH are often excluded from clinical trials for CAR-T. This study sought to explore current access to clinical trials for CAR-T for PWH. Methods: We searched ClinicalTrials.gov through May 20th, 2025, for all interventional clinical trials related to CAR-T for the treatment of NHL. Studies primarily for adult patients (>=18 years old) with at least one trial site in the contiguous United States were included. All trials were reviewed individually for relevance and whether PWH were eligible. Analysis of current access was based on studies actively enrolling on May 20th, 2025. Zip codes for each trial site were extracted and travel time to the nearest trial was calculated for each zip code for trials that included or excluded PWH. Demographic data including race/ethnicity, socioeconomic status, and insurance status were extracted from the 2020 Census for analysis. Unpaired t-test and chi-squared test were used, and a p-value of <0.05 was considered significant. Results: 254 trials were eligible for review with 80 meeting criteria for inclusion and actively recruiting. 11 (13.7%) trials included PWH, 59 (73.8%) excluded PWH, and 10 (12.5%) did not mention HIV. Most trials (80.0%) were phase 1; a significantly greater proportion of phase 2 trials excluded PWH compared to phase 1 trials (65.4% vs. 10.9%, p<0.001). The median number of sites per trial was one (range 1-76). Median population-weighted travel time to trials including PWH was 1.15 (interquartile range [IQR] 0.49-2.38) hours which was significantly longer than for trials excluding PWH (0.84, IQR 0.40-1.91 hours, p<0.001). Trials that included PWH had significantly less access compared to trials that excluded PWH for both one-hour (46.1% vs. 55.3%, p<0.001) and three-hour (82.2% vs. 87.7%, p<0.001) access. The South had longer travel time to trials including PWH (1.70, IQR 0.69-2.99 hours) compared to trials excluding PWH (0.92, IQR 0.46-2.00 hours, p<0.001). Median travel time for PWH for zip codes in the first (lowest) quartile of median household income was 1.80 (IQR 0.55-3.06) hours which was significantly longer than for the fourth (highest) quartile with median time of 0.73 (IQR 0.44-1.26) hours (p<0.001). Conclusions: There are significant disparities in geospatial access to clinical trials for CAR-T for PWH. Paradoxically, access for PWH remains particularly poor in the South where there is the highest prevalence of HIV. For PWH, lower median income is also associated with significantly longer travel times. Despite efforts to reduce clinical trial exclusion based solely on HIV status, access to trials for PWH remains disproportionately lower compared to persons without HIV. Further efforts are needed to increase access to clinical trials for underserved and underrepresented populations, with particular focus on PWH. Citation Format: Luke Maillie, Matthew Sisk, Anna Coghill, Nathan Van Bibber, Carmen Guerra, David M. Aboulafia, Thomas M. Atkinson, Stefan K. Barta. Geospatial access to CAR-T clinical trials for non-Hodgkin lymphoma in the United States: Are persons with HIV included? [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr C100.

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Journal
Cancer Epidemiology Biomarkers & Prevention
Published
2025-09-18
DOI
https://doi.org/10.1158/1538-7755.disp25-c100
Primary Topic
Biomedical Ethics and Regulation
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article
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article

Abstract C100: Geospatial access to CAR-T clinical trials for non-Hodgkin lymphoma in the United States: Are persons with HIV included?

Matthew Sisk, Anna E. Coghill, Nathan Van Bibber, Thomas M. Atkinson et al.
Cancer Epidemiology Biomarkers & Prevention
Biomedical Ethics and Regulation
article

Abstract C100: Geospatial access to CAR-T clinical trials for non-Hodgkin lymphoma in the United States: Are persons with HIV included?

Matthew Sisk, Anna E. Coghill, Nathan Van Bibber, Thomas M. Atkinson, Stefan Klaus Barta, Carmen Guerra, Luke Maillie, David M. Aboulafia
article en

Abstract

Abstract Introduction: Chimeric antigen receptor T-cell (CAR-T) therapy is a paradigm-changing therapy in the treatment of non-Hodgkin Lymphoma (NHL). While NHL is the leading cause of cancer-related death for persons living with HIV (PWH) in high-income countries, PWH are often excluded from clinical trials for CAR-T. This study sought to explore current access to clinical trials for CAR-T for PWH. Methods: We searched ClinicalTrials.gov through May 20th, 2025, for all interventional clinical trials related to CAR-T for the treatment of NHL. Studies primarily for adult patients (>=18 years old) with at least one trial site in the contiguous United States were included. All trials were reviewed individually for relevance and whether PWH were eligible. Analysis of current access was based on studies actively enrolling on May 20th, 2025. Zip codes for each trial site were extracted and travel time to the nearest trial was calculated for each zip code for trials that included or excluded PWH. Demographic data including race/ethnicity, socioeconomic status, and insurance status were extracted from the 2020 Census for analysis. Unpaired t-test and chi-squared test were used, and a p-value of <0.05 was considered significant. Results: 254 trials were eligible for review with 80 meeting criteria for inclusion and actively recruiting. 11 (13.7%) trials included PWH, 59 (73.8%) excluded PWH, and 10 (12.5%) did not mention HIV. Most trials (80.0%) were phase 1; a significantly greater proportion of phase 2 trials excluded PWH compared to phase 1 trials (65.4% vs. 10.9%, p<0.001). The median number of sites per trial was one (range 1-76). Median population-weighted travel time to trials including PWH was 1.15 (interquartile range [IQR] 0.49-2.38) hours which was significantly longer than for trials excluding PWH (0.84, IQR 0.40-1.91 hours, p<0.001). Trials that included PWH had significantly less access compared to trials that excluded PWH for both one-hour (46.1% vs. 55.3%, p<0.001) and three-hour (82.2% vs. 87.7%, p<0.001) access. The South had longer travel time to trials including PWH (1.70, IQR 0.69-2.99 hours) compared to trials excluding PWH (0.92, IQR 0.46-2.00 hours, p<0.001). Median travel time for PWH for zip codes in the first (lowest) quartile of median household income was 1.80 (IQR 0.55-3.06) hours which was significantly longer than for the fourth (highest) quartile with median time of 0.73 (IQR 0.44-1.26) hours (p<0.001). Conclusions: There are significant disparities in geospatial access to clinical trials for CAR-T for PWH. Paradoxically, access for PWH remains particularly poor in the South where there is the highest prevalence of HIV. For PWH, lower median income is also associated with significantly longer travel times. Despite efforts to reduce clinical trial exclusion based solely on HIV status, access to trials for PWH remains disproportionately lower compared to persons without HIV. Further efforts are needed to increase access to clinical trials for underserved and underrepresented populations, with particular focus on PWH. Citation Format: Luke Maillie, Matthew Sisk, Anna Coghill, Nathan Van Bibber, Carmen Guerra, David M. Aboulafia, Thomas M. Atkinson, Stefan K. Barta. Geospatial access to CAR-T clinical trials for non-Hodgkin lymphoma in the United States: Are persons with HIV included? [abstract]. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr C100.

Cancer Epidemiology Biomarkers & PreventionVol. 34(9_Supplement)
University of Notre Dame (US), Virginia Mason Medical Center (US), Memorial Sloan Kettering Cancer Center (US), Moffitt Cancer Center (US), Kettering University (US), University of Pennsylvania (US)
Openalex Percentile: Top 68%
Biomedical Ethics and Regulation
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