Importance: Chimeric antigen receptor T-cell (CAR-T) therapy is a paradigm-changing therapy in treating non-Hodgkin lymphoma (NHL). Although NHL is a leading cause of cancer-attributable deaths for persons living with HIV (PWH) in high-income countries, PWH are frequently excluded from CAR-T clinical trials. Objective: To explore access to CAR-T trials for the general population and PWH. Design, Setting, and Participants: This cross-sectional study queried ClinicalTrials.gov for all interventional CAR-T clinical trials for the treatment of NHL. Zip codes for each trial site were extracted, and travel time to the nearest location was calculated. Trials included had at least 1 trial site in the contiguous US, and were actively recruiting trials for adult patients (aged ≥18 years) as of May 20, 2025. Exposure: All trials were reviewed for relevance and eligibility of PWH. Main Outcomes and Measures: The primary outcomes were median population-weighted travel time to the nearest trial and 1-hour and 3-hour access for the general population, HIV-inclusive trials, and HIV-exclusive trials. Proportions were compared using a χ2 test, and continuous median travel times were compared using unpaired t tests. Results: In total, 254 trials were eligible for review, and 80 met criteria for inclusion with 11 (13.8%) trials including PWH, 58 (72.5%) excluding PWH, and 11 (13.8%) not mentioning HIV. The median (IQR) population-weighted travel time was 0.73 (0.36-1.64) hours for the general population, 1.15 (0.49-2.38) hours for trials including PWH, and 0.84 (0.40-1.91) hours for trials excluding PWH. Compared with trials that excluded PWH, trials that included PWH had significantly lower 1-hour (46.07% 95% CI, 46.06%-46.07% vs 55.27% 95% CI, 55.27%-55.28%; P < .001) and 3-hour (82.22% 95% CI, 82.22%-82.23% vs 87.76% 95% CI, 87.75%-87.76%; P < .001) access. Travel time in the South was significantly longer for trials that included PWH compared with trials that excluded PWH (median IQR, 1.70 0.69-2.99 hours vs 0.92 0.46-2.00 hours; P < .001). Conclusions and Relevance: This cross-sectional study of travel time to CAR-T trials found that PWH had to travel significantly longer than the general population to reach the nearest trial. Despite efforts to reduce clinical trial exclusion based solely on HIV status, access for PWH remains disproportionately lower compared with the general population, and particularly poor in the South, where there is the highest prevalence of HIV. Further efforts to increase access to trials for underserved and underrepresented populations, particularly for PWH, are needed.
Maillie et al. (Fri,) studied this question.