Cancer Sci. 2015 Dec;106(12):1761-71. doi: 10.1111/cas.12819.
The development of cancer immunotherapies is progressing rapidly with a variety of technological approaches. They consist of "cancer vaccines", which are based on the idea of vaccination, "effector cell therapy", classified as passive immunotherapy, and "inhibition of immunosuppression", which intends to break immunological tolerance to autoantigens or immunosuppressive environments characterizing antitumor immune responses. Recent reports showing clinical evidence of efficacy of immune checkpoint inhibitors and adoptive immunotherapies with tumor-infiltrating lymphocytes and tumor-specific receptor gene-modified T cells indicate the beginning of a new era for cancer immunotherapy. This guidance summarizes ideas that will be helpful to those who plan to develop cancer immunotherapy. The aims of this guidance are to discuss and offer important points in early phase clinical studies of innovative cancer immunotherapy, with future progress in this field, and to contribute to the effective development of cancer immunotherapy aligned with the scope of regulatory science. This guidance covers cancer vaccines, effector cell therapy, and inhibition of immunosuppression, including immune checkpoint inhibitors.
癌症免疫疗法正通过多种技术手段迅速发展。它们包括基于疫苗接种理念的“癌症疫苗”、归类为被动免疫疗法的“效应细胞疗法”，以及旨在打破针对自身抗原的免疫耐受或抗肿瘤免疫反应所特有的免疫抑制环境的“免疫抑制抑制”。最近有报告显示免疫检查点抑制剂以及采用肿瘤浸润淋巴细胞和肿瘤特异性受体基因修饰T细胞的过继性免疫疗法具有临床疗效证据，这标志着癌症免疫疗法新时代的开端。本指南总结了一些对计划开展癌症免疫疗法研发的人员有帮助的观点。本指南的目的是讨论并提供创新性癌症免疫疗法早期临床研究中的要点，以推动该领域的未来进展，并有助于按照监管科学的范畴有效地开展癌症免疫疗法。本指南涵盖癌症疫苗、效应细胞疗法以及免疫抑制抑制，包括免疫检查点抑制剂。
