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Regulatory T cell therapies to treat autoimmune diseases and transplant rejection

Regulatory T cell therapies have shown promise for treating autoimmune diseases and aiding transplantation. We summarize a recent NIAID/HESI-sponsored workshop that addressed key issues in non-clinical and clinical development vital to advancing this immune tolerance paradigm.

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Fig. 1: Engineering approaches to enhance Treg cell therapeutics.
Fig. 2: Regulatory cell therapy approaches to treat inflammation, autoimmune diseases and organ transplantation.

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Acknowledgements

HESI, NIAID and the workshop organizing committee (J.A.B., M.D.F., H.L., M.L., G. Nepom, L.P.M., G. Price, J.R., P.R., M.G.R., D.R. and M. Sykes). We would also like to thank the speakers (Supplementary Information, Appendix A) and organizations that contributed content to the workshop.

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Correspondence to Jeffrey A. Bluestone.

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Competing interests

The event was supported by HESI’s Cell Therapy- Tracking, Circulation and Safety (CT-TRACS) and Immunosafety committees; a grant from Genentech, a member of the Roche Group (Scientific and Research Focused Giving P-19309); as well as donations from the following sponsors: Abata Therapeutics, AbbVie, Alexandria Venture Investments, Amgen, AstraZeneca, Bristol-Myers Squibb, GentiBio, PolTREG S.A., Quell Therapeutics, Sonoma Biotherapeutics and T1D Fund. J.A.B. and H.L. are employees of Sonoma Biotherapeutics and have an equity stake in the company. M.G.R. is an employee of Tr1X and has an equity stake in the company. None of the other authors have conflicts to declare.

Supplementary information

Appendix A:

Invited participants and speakers.

Appendix B:

Treg cell therapy studies.

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Bluestone, J.A., Burnett, B.K., Crute, C.E. et al. Regulatory T cell therapies to treat autoimmune diseases and transplant rejection. Nat Immunol 26, 819–824 (2025). https://doi.org/10.1038/s41590-025-02154-2

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