AbstractRegulatory T (Treg) cells are a suppressive subset of CD4+ T cells that maintain immune homeostasis and restrain inflammation. Three decades after their discovery, the promise of strategies to harness Treg cells for therapy has never been stronger. Multiple clinical trials seeking to enhance endogenous Treg cells or deliver them as a cell-based therapy have been performed and hint at signs of success, as well as to important limitations and unanswered questions.

摘要调节性T（Treg）细胞是CD4+T细胞的抑制性子集，可维持免疫稳态并抑制炎症。在他们被发现三十年后，利用Treg细胞进行治疗的策略的前景从未如此强大。已经进行了多项旨在增强内源性Treg细胞或将其作为基于细胞的疗法的临床试验，并暗示了成功的迹象，以及重要的局限性和未解决的问题。

Strategies to deplete Treg cells in cancer are also in active clinical testing. Furthermore, multi-dimensional methods to interrogate the biology of Treg cells are leading to a refined understanding of Treg cell biology and new approaches to harness tissue-specific functions for therapy. A new generation of Treg cell clinical trials is now being fuelled by advances in nanomedicine and synthetic biology, seeking more precise ways to tailor Treg cell function.

消耗癌症中Treg细胞的策略也在积极的临床测试中。此外，询问Treg细胞生物学的多维方法正在导致对Treg细胞生物学的精细理解以及利用组织特异性功能进行治疗的新方法。纳米医学和合成生物学的进步正在推动新一代Treg细胞临床试验，寻求更精确的方法来定制Treg细胞功能。

This Review will discuss recent advances in our understanding of human Treg cell biology, with a focus on mechanisms of action and strategies to assess outcomes of Treg cell-targeted therapies. It highlights results from recent clinical trials aiming to enhance or inhibit Treg cell activity in a variety of diseases, including allergy, transplantation, autoimmunity and cancer, and discusses ongoing strategies to refine these approaches..

本综述将讨论我们对人类Treg细胞生物学理解的最新进展，重点是评估Treg细胞靶向治疗结果的作用机制和策略。它强调了最近旨在增强或抑制多种疾病（包括过敏，移植，自身免疫和癌症）中Treg细胞活性的临床试验的结果，并讨论了改进这些方法的持续策略。。

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Fig. 1: Three phases of Treg cell-mediated immune suppression.Fig. 2: Tracking Treg cells in clinical studies.Fig. 3: Treg cell therapy steps and considerations.Fig. 4: Clinical trials of Treg cell therapy.Fig. 5: Evolution of Treg therapies.

图1:Treg细胞介导的免疫抑制的三个阶段。图2：在临床研究中追踪Treg细胞。图3:Treg细胞治疗步骤和注意事项。。图5:Treg疗法的演变。

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Download referencesAcknowledgementsThe authors’ work in this area is funded by the Canadian Institutes for Health Research (CIHR; FDN-154304), Juvenile Diabetes Research Foundation Canada (3-COE-2022-1103-M-B), U.S. Department of Defense/Reconstructive Transplant Research Program (HT94252310626), and the Leona M.

下载参考文献致谢作者在这方面的工作由加拿大卫生研究院（CIHR；FDN-154304），加拿大青少年糖尿病研究基金会（3-COE-2022-1103-M-B），美国国防部/重建移植研究计划（HT94252310626）和Leona M。

and Harry B. Helmsley Charitable Trust. C.M.W. is supported by a CIHR doctoral award. D.A.B. was supported by fellowships from the CIHR and Michael Smith Health Research BC. M.K.L. is Canada Research Chair in Immune Engineering and receives a Scientist Salary Award from the BC Children’s Hospital Research Institute.

和Harry B.Helmsley慈善信托基金。C、 M.W.获得了CIHR博士学位的支持。D、 。M、 K.L.是加拿大免疫工程研究主席，并获得不列颠哥伦比亚省儿童医院研究所颁发的科学家工资奖。

We thank K. Salim for providing sample flow plots displayed in Fig. 2.Author informationAuthors and AffiliationsBC Children’s Hospital Research Institute, Vancouver, British Columbia, CanadaChristine M. Wardell, Dominic A. Boardman & Megan K. LevingsDepartment of Surgery, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, CanadaChristine M.

我们感谢K.Salim提供图2所示的样本流程图。作者信息作者和所属机构BC儿童医院研究所，不列颠哥伦比亚省温哥华，CanadaChristine M.Wardell，Dominic A.Boardman＆Megan K.LevingsDepartment of Surgery，Faculty of Medicine，不列颠哥伦比亚大学，温哥华，不列颠哥伦比亚省，CanadaChristine M。

Wardell, Dominic A. Boardman & Megan K. LevingsSchool of Biomedical Engineering, University of British Columbia, Vancouver, British Columbia, CanadaMegan K. LevingsAuthorsChristine M. WardellView author publicationsYou can also search for this author in.

Wardell，Dominic A.Boardman＆Megan K.LevingsSchool of Biomedical Engineering，不列颠哥伦比亚大学，温哥华，不列颠哥伦比亚，CanadaMegan K.LevingsAuthorsChristine M.WardellView作者出版物您也可以在中搜索这位作者。

PubMed Google ScholarDominic A. BoardmanView author publicationsYou can also search for this author in

PubMed Google ScholarDominic A.BoardmanView作者出版物您也可以在

PubMed Google ScholarMegan K. LevingsView author publicationsYou can also search for this author in

PubMed Google ScholarMegan K.LevingsView作者出版物您也可以在

PubMed Google ScholarContributionsC.M.W. and M.K.L. conceived the article. All authors contributed to the research, writing and editing of the manuscript.Corresponding authorCorrespondence to

PubMed谷歌学术贡献中心。M、 。所有作者都为稿件的研究，撰写和编辑做出了贡献。对应作者对应

Megan K. Levings.Ethics declarations

。道德宣言

Competing interests

相互竞争的利益

M.K.L. is a science advisory board member for Anokion, advises for and holds shares in Integrated Nanotherapeutics, and is an inventor on patent applications related to A2-chimaeric antigen receptor regulatory T cells with licensed technology to Sangamo Therapeutics. C.M.W. and D.A.B. declare no competing interests..

M、 K.L.是Anokion的科学顾问委员会成员，为综合纳米治疗药物提供建议并持有其股份，并且是与A2嵌合抗原受体调节性T细胞相关的专利申请的发明人，拥有Sangamo Therapeutics的许可技术。C、 M.W.和D.A.B.声明没有利益冲突。。

Peer review

同行评审

Peer review information

同行评审信息

Nature Reviews Drug Discovery thanks Leonardo Ferreira and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

《自然评论》药物发现感谢莱昂纳多·费雷拉（LeonardoFerreira）和另一位匿名审稿人对这项工作的同行评审做出的贡献。

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Additional informationPublisher的注释Springer Nature在已发布的地图和机构隶属关系中的管辖权主张方面保持中立。相关链接ClinicalTrials.gov：https://clinicaltrials.gov/EudraCT:（笑声）https://eudract.ema.europa.eu/Rights和许可证原告性质或其许可人（例如。

a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.Reprints and permissionsAbout this articleCite this articleWardell, C.M., Boardman, D.A.

协会或其他合作伙伴）根据与作者或其他权利持有人的出版协议对本文拥有专有权；。转载和许可本文引用本文沃德尔，C.M.，博德曼，D.A。

& Levings, M.K. Harnessing the biology of regulatory T cells to treat disease..

&Levings，M.K.利用调节性T细胞的生物学来治疗疾病。。

Nat Rev Drug Discov (2024). https://doi.org/10.1038/s41573-024-01089-xDownload citationAccepted: 25 October 2024Published: 16 December 2024DOI: https://doi.org/10.1038/s41573-024-01089-xShare this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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Applied immunologyAutoimmunityCell deliveryImmunotherapyTranslational research

应用免疫学自动免疫细胞传递免疫治疗翻译研究