Department of Pathology and Laboratory Medicines, University of Pennsylvania Perelman School of Medicine, Abramson Family Cancer Research Institute, 422 Curie Boulevard, Stellar-Chance Laboratories, Philadelphia, PA 19104-4283, USA.
J Transl Med. 2011 Aug 19;9:138. doi: 10.1186/1479-5876-9-138.
T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.
T 细胞疗法代表了一种新兴且有前途的治疗传染病和癌症的方法。最近临床试验的数据强调了这种治疗方式具有强大的抗肿瘤活性的潜力。生物标志物是指从患者中测量的提供有关治疗效果信息的生物学参数，在新型治疗药物的开发中起着核心作用。在缺乏关于主要临床终点的信息的情况下，生物标志物可以提供关键的见解，使研究人员能够指导候选产品的临床开发。在细胞治疗试验的背景下，生物标志物的定义可以扩展到包括对细胞产品的重要产品生物活性的参数的描述。本文将重点介绍与 T 细胞治疗试验相关的生物标志物研究，更具体地说：i. 专门与 T 细胞治疗试验相关的生物标志物的类别和分类的概述和描述，以及 ii. 深入了解未来的方向和挑战，以适当开发生物标志物来评估 T 细胞治疗试验的产品生物活性和治疗效果。
