CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Geographic and Racial Disparities in Access to Chimeric Antigen Receptor-T Cells and Bispecific Antibodies Trials for Multiple Myeloma.
Geographic and Racial Disparities in Access to Chimeric Antigen Receptor-T Cells and Bispecific Antibodies Trials for Multiple Myeloma.
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在这项横断面研究中,我们发现 CAR-T 和双特异性抗体临床试验的地理分布,可能导致在多发性骨髓瘤新疗法最先进临床试验的可及性方面存在差异。
评估用于多发性骨髓瘤的CAR-T 和双特异性抗体治疗在地域上的分布,是否能让黑人患者公平获得治疗。研究设计、地点和对象:本横断面研究分析截至2022年1月31日ClinicalTrials.gov登记的所有可用多发性骨髓瘤CAR-T 和双特异性抗体临床试验;仅纳入至少有一个美国开放研究中心的试验。数据于2022年2月分析。
共发现162项临床试验,其中69项纳入分析;这些试验已纳入或预计纳入7896名参与者,其中4386人(55.5%)已参加或预计参加CAR-T 临床试验。绝大多数临床试验由产业界发起(66项,占96%),共有140个研究中心。每项试验平均有8.1个研究中心(CAR-T 试验平均7.8个,范围1–30;双特异性抗体试验平均8.7个,范围1–26)。仅35.9%的黑人患者居住在有开放试验的县。在黑人居民比例最高的10个州(占18.6%–41.4%)中,有6个州(60%)没有开放任何相关试验(3个州),或CAR-T 及双特异性抗体试验开放数均少于3项(3个州)。结论与意义:本横断面研究发现,CAR-T 和双特异性抗体临床试验的地理分布可能加剧患者获得多发性骨髓瘤先进疗法临床试验的差距。鉴于大多数在研试验由产业界赞助,规范临床试验研究中心的地域布局或有助于减少这种不公平。
The use of chimeric antigen receptor-T cell (CAR-T) therapy and bispecific antibodies in multiple myeloma is expanding, with encouraging early results. It is unknown if the current geographic distribution of CAR-T therapy and bispecific antibodies in multiple myeloma allows access for patients in need, especially for Black populations, which have a higher incidence of multiple myeloma.
To investigate if the current geographic distribution of CAR-T cell therapy and bispecific antibodies for multiple myeloma allows equitable access for Black patients with multiple myeloma. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of data from CAR-T therapy and bispecific antibodies multiple myeloma clinical trials for all available studies listed in ClinicalTrials.gov until January 31, 2022. Only studies with 1 or more open sites in the US were analyzed. Data were analyzed February 2022.
A total of 162 clinical trials were found, and 69 analyzed-7896 participants were either enrolled or expected to enroll, with 4386 participants (55.5%) enrolled or to be enrolled in CAR-T therapies clinical trials. The vast majority of clinical trials (66 [96%]) were sponsored by industry, and there were 140 clinical trials sites. The mean number of sites per trial was 8.1 (7.8 for CAR-T trials [range, 1-30 trials] vs 8.7 for bispecific antibodies [range, 1-26 trials]). Only 35.9% of Black patients lived in a county with an open trial. For the 10 states with the highest proportion of Black residents (ranging from 18.6% to 41.4%), 6 of those states (60%) had no (3 states) or less than 3 clinical trial openings (3 states) for either a CAR-T or bispecific antibody study.
In this cross-sectional study, we found that the geographic distribution of clinical trials for CAR-T and bispecific antibodies may contribute to disparities in access to the most advanced clinical trials for new multiple myeloma therapies. Since most of the ongoing trials were sponsored by industry, regulating the distribution of clinical trial sites may reduce these inequities.
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