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. 2024 Feb 6;15:899. doi: 10.1038/s41467-024-45056-x

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© The Author(s) 2024

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 2 — To develop an antigen-specific Treg targeting an autoimmune disease a 6-step process is undertaken. In the case of lupus nephritis, Sm-Tregs are developed as follows. (1) The immunogenic autoimmune epitope, the Smith antigen (Sm), in the context of human leukocyte antigen (HLA)-DR15 is identified. (2) T-cell receptors (TCRs) are identified specific for Sm. (3) Candidate TCRs are screened for high expression, specificity and reactivity and a lead Sm TCR is chosen. (4) Lead Sm TCR is validated for its functional responses on Tregs in vitro and in vivo. (5) The pre-clinical data package is sent for regulatory approval and good manufacturing practice (GMP) cell manufacture commences. (6) Sm-Tregs are tested in human clinical trials for safety and efficacy. Created with BioRender.com.