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an immunological and regulatory challenge

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发表于 2015-8-18 08:42:56 | 显示全部楼层 |阅读模式
标题:
Orchestrating an immuneresponse against cancer with engineered immune cells expressing αβTCRs, CARs,and innate immune receptors: an immunological and regulatory challenge
Abstract Over half a century ago, the first allogeneicstem cell transplantation (allo-SCT) initiated cellular immunotherapy. Forseveral decades, little progress was made, and toxicity of allo-SCT remained amajor challenge. However, recent breakthroughs have opened new avenues tofurther develop this modality and to provide less toxic and equally efficientinterventions for patients suffering from hematological or solid malignancies.Current novel cellular immune interventions include ex vivo expansion andadoptive transfer of tumor infiltrating immune cells or administration of drugswhich antagonize tolerizing mechanisms. Alternatively, transfer of immune cellsengineered to express defined T cell receptors(TCRs) and chimeric antigenreceptors (CARs) has shownits potential. A valuable addition to ‘engineered’adaptive immunity has emerged recently through the improved
understanding of how innate immune cells can attackcancer cells without substantial side effects. This has enabledthe developmentof transplantation platforms with limitedside effects allowing early immuneinterventions as well asthe design of engineered immune cells expressing innateimmunereceptors. Here, we focus on innate immuneinterventions and their orchestrationwith TCR- and CAR-engineered immune cells. In addition, we discuss how theexploitationof the full potential of cellular immune interventions is influenced byregulatory frameworks. Finally, we highlight and discuss substantialdifferences in the current landscape of clinical trials in Europe as comparedto the USA. The aim is to stimulate international efforts to support regulatoryauthorities and funding agencies, especially in Europe, to create anenvironment that will endorse the development of engineered immune cells for thebenefit of patients.
摘要:
爱康得生物编译:半个多世纪前,第一例异基因造血干细胞移植(allo-SCT)开启了细胞免疫治疗的历史。但在过去几十年来,该疗法并没有没有取得太大的进展,异基因移植的带来的毒性仍然是一个重大的挑战。然而,最近的技术突破为未来的发展带来了一个新的途径,可为血液肿瘤和实体瘤患者提供毒性更小但同样有效的治疗方式。目前的新型细胞免疫治疗包括体外扩增相应的免疫细胞或对药物耐受的管理。此外,通过回输经改造的可表达TCRCART细胞已经显示出惊人的疗效。这种改造更是能让我们理解免疫细胞如何攻击肿瘤但不带来实质性的副作用。这促成了副作用很小的移植平台的发展,允许早期免疫干预以及表达天然免疫受体的工程化免疫细胞的设计。 在这里,我们专注于先天免疫干预和由此发展来得TCR-TCAR-T免疫细胞。此外,我们将讨论细胞免疫干预的全部潜力的开发是如何由监管框架影响的。最后,我们强调并讨论,美国在欧洲的临床试验目前出现的重大分歧。这样做的目的是为了促进国际间的合作,以支持监管机构和融资机构,尤其是在欧洲,以创建支持免疫细胞改造,造福患者的环境。

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