Wistar Institute, USA.
Cancer Res. 2011 May 1;71(9):3175-81. doi: 10.1158/0008-5472.CAN-10-4035.
T cells that are genetically modified to express single-chain chimeric antigen receptors (CAR) have shown promise in early cancer immunotherapy clinical trials. Unfortunately, 2 recent deaths in cancer patients treated with CAR T cells have created some uncertainty on how to best mitigate patient risk, while continuing to advance this very promising therapeutic avenue. In order to address these concerns, the Recombinant DNA Advisory Committee (RAC) held a symposium, the objectives of which were to first review the reported treatment-associated toxicities and, second, to discuss methods for improving safety and efficacy. This report highlights the issues raised as part of this discussion, with a specific focus on protocols infusing CAR T cells. Because this was not a consensus conference, the opinions described should not be construed to represent those of any individual RAC member, the RAC as a body, conference participants, the National Institutes of Health, or the U.S. Food and Drug Administration.
经过基因修饰表达嵌合抗原受体（CAR）的 T 细胞在癌症免疫治疗的早期临床试验中显示出良好的效果。不幸的是，最近有 2 例接受 CAR T 细胞治疗的癌症患者死亡，这对如何最好地降低患者风险产生了一些不确定性，同时也在继续推进这一非常有前途的治疗途径。为了解决这些问题，重组 DNA 咨询委员会（RAC）举办了一次研讨会，其目标首先是回顾报告的与治疗相关的毒性，其次是讨论提高安全性和疗效的方法。本报告重点介绍了此次讨论中提出的问题，特别关注输注 CAR T 细胞的方案。由于这不是一次共识会议，因此所描述的意见不应被解释为代表任何个别 RAC 成员、RAC 作为一个团体、会议参与者、美国国立卫生研究院或美国食品和药物管理局的意见。
