Considerations for the clinical application of chimeric antigen receptor T cells: observations from a recombinant DNA Advisory Committee Symposium held June 15, 2010.
Considerations for the clinical application of chimeric antigen receptor T cells: observations from a recombinant DNA Advisory Committee Symposium held June 15, 2010.
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DOI：
10.1158/0008-5472.can-10-4035
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发表时间：
2011-05-01
期刊：
影响因子：
11.2
通讯作者：
Strome SE
中科院分区：
文献类型：
--
作者：
Ertl HC;Zaia J;Rosenberg SA;June CH;Dotti G;Kahn J;Cooper LJ;Corrigan-Curay J;Strome SE
经基因修饰表达单链嵌合抗原受体(CARS)的T细胞在早期癌症免疫治疗临床试验中显示出良好的前景。不幸的是，最近两例接受CAR-T细胞治疗的癌症患者的死亡给如何最好地降低患者风险，同时继续推进这一非常有希望的治疗途径带来了一些不确定性。为了解决这些问题，重组DNA咨询委员会(RAC)举行了一次研讨会，目的是首先审查已报道的与治疗相关的毒性，其次讨论提高安全性和有效性的方法。这份报告强调了作为讨论的一部分提出的问题，并特别关注注入CAR-T细胞的方案。由于这不是一次协商一致的会议，所描述的意见不应被解释为代表任何RAC成员、RAC作为一个机构、会议参与者、NIH或FDA的意见。
T cells which are genetically modified to express single-chain chimeric antigen receptors (CARs) have shown promise in early cancer immunotherapy clinical trials. Unfortunately, two 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, NIH or the FDA.