肿瘤细胞治疗研究
英文原题：Geospatial Access to CAR-T Clinical Trials for Non-Hodgkin Lymphoma for Persons With HIV.
这项针对前往 CAR-T 试验所需交通时间的横断面研究发现，PWH 前往最近试验机构所需的时间显著长于普通人群。
重要性：CAR-T 细胞疗法改变了非霍奇金淋巴瘤（NHL）的治疗模式。尽管在高收入国家，NHL是HIV感染者（PWH）癌症相关死亡的重要原因之一，但PWH经常被排除在CAR-T临床试验之外。 目的：探讨普通人群和PWH获得CAR-T试验的可及性。 设计、场所和参与者：本横断面研究检索ClinicalTrials.gov中所有用于治疗NHL的干预性CAR-T临床试验，提取各试验中心邮政编码，并计算至最近中心的旅行时间。纳入至少有1个试验中心位于美国本土连续州、截至2025年5月20日正在招募成年患者（年龄18岁）的试验。 暴露：审查所有试验对PWH的相关性及其入组资格。 主要结局和测量指标：主要结局为普通人群、纳入HIV感染者的试验和排除HIV感染者的试验中，按人口加权的至最近试验中心旅行时间中位数，以及1小时和3小时内的可及性。比例采用卡方检验比较，连续型旅行时间中位数采用非配对t检验比较（原文统计检验符号有缺失）。 结果：共254项试验符合审查条件，其中80项符合纳入标准：11项（13.8%）纳入PWH，58项（72.5%）排除PWH，11项（13.8%）未提及HIV。按人口加权的旅行时间中位数（四分位距，IQR）为：普通人群0.73（0.36–1.64）小时，纳入PWH的试验1.15（0.49–2.38）小时，排除PWH的试验0.84（0.40–1.91）小时。与排除PWH的试验相比，纳入PWH的试验中，1小时内可及比例显著较低（46.07%［95% CI，46.06%–46.07%］对55.27%［95% CI，55.27%–55.28%］；P<0.001），3小时内可及比例也显著较低（82.22%［95% CI，82.22%–82.23%］对87.76%［95% CI，87.75%–87.76%］；P<0.001）。在美国南部，纳入PWH的试验旅行时间显著长于排除PWH的试验（中位数［IQR］1.70［0.69–2.99］小时对0.92［0.46–2.00］小时；P<0.001）。 结论与意义：这项关于CAR-T试验旅行时间的横断面研究发现，PWH前往最近试验中心所需时间显著长于普通人群。尽管已努力减少仅因HIV状态而排除患者的情况，PWH获得试验的机会仍明显低于普通人群；在HIV患病率最高的美国南部，这一差距尤其突出。需要进一步努力提高服务不足和代表性不足人群，特别是PWH，参与试验的可及性。
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 2 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.
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