The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US Food and Drug Administration and other agencies worldwide for two types of hematologic cancers. To facilitate the development of these therapies for patients with life-threatening cancers with limited or no therapeutic options, science- and risk-based approaches will be critical to mitigating and balancing any potential risk associated with either early clinical research or more flexible manufacturing paradigms. Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy convened an expert group of stakeholders to develop specific strategies and proposals for regulatory opportunities to accelerate the development of cell therapies as promising new therapeutics. This meeting took place in Washington, DC on May 17, 2019. As academia and industry expand research efforts and cellular product development pipelines, this report summarizes opportunities to accelerate entry into the clinic for exploratory studies and optimization of cell products through manufacturing improvements for these promising new therapies.

中文翻译：

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加快开发用于治疗癌症的创新细胞治疗产品

细胞治疗领域正迅速成为肿瘤学研究和药物开发的优先领域。目前，美国食品和药物管理局和全球其他机构批准了两种嵌合抗原受体 T 细胞疗法，用于治疗两种类型的血液癌症。为了促进针对治疗选择有限或没有治疗选择的危及生命的癌症患者开发这些疗法，基于科学和风险的方法对于减轻和平衡与早期临床研究或更灵活的制造范式相关的任何潜在风险至关重要。癌症研究之友和帕克癌症免疫疗法研究所召集了一个利益相关者专家组，为监管机会制定具体的战略和建议，以加速细胞疗法作为有前途的新疗法的发展。本次会议于 2019 年 5 月 17 日在华盛顿特区举行。 随着学术界和工业界扩大研究工作和细胞产品开发管道，本报告总结了通过制造改进加速进入临床进行探索性研究和优化细胞产品的机会。有希望的新疗法。