Technical University Munich, Faculty of Medicine, TUMCells Interdisciplinary Center for Cellular Therapies, Munich, Germany.
University College Hospital, Research Department of Hematology, London, United Kingdom.
Cytotherapy. 2014 Apr;16(4 Suppl):S120-9. doi: 10.1016/j.jcyt.2014.02.001.
This review is intended to reflect upon the current status and perspectives of cell-based immunotherapy at a time when the promise of extensive pre-clinical research has been translated into encouraging clinical responses. However, some of these have also been complicated by significant adverse reactions. As the field moves towards definitive late stage trials, with a growing interest from pharmaceutical companies, we realize that novel cell therapy strategies pose questions that are familiar to traditional drug development, along with new considerations due to the potential of T cells to persist long term and to expand after adoptive transfer. These questions address the safety of the product, the efficacy, the mode of action, and the anticipation of risks. From different perspectives, we intend to address exciting opportunities and safety concerns in current concepts of cellular immunotherapy.
这篇综述旨在反映细胞免疫疗法的现状和展望,因为目前广泛的临床前研究的承诺已经转化为令人鼓舞的临床反应。然而,其中一些也因严重的不良反应而变得复杂。随着该领域进入有制药公司越来越感兴趣的确定性后期试验,我们意识到新型细胞治疗策略提出了一些与传统药物开发相似的问题,同时由于 T 细胞具有长期持续存在和过继转移后扩增的潜力,也带来了新的考虑因素。这些问题涉及产品的安全性、疗效、作用模式和风险预测。我们拟从不同角度探讨细胞免疫治疗的当前概念中的令人兴奋的机遇和安全性问题。