Treg cell therapy holds immense potential to revolutionize the treatment of inflammatory and autoimmune diseases by restoring immunological balance. Although significant progress has been made in improving the stability and specificity of Treg cell therapy, successful clinical application of Treg cell therapy remains elusive. Key considerations include the selection of starting sources and choices of Treg subtypes, engineering the desired specificity and functionality, addressing manufacturability bottleneck, and designing optimal clinical trials. This series serves to integrate key facets, emerging concepts, and regulatory/safety considerations for successful Treg cell therapy development and clinical applications.

Despite the tremendous potential for Treg-directed cell therapy to be a transformative therapeutic modality for various inflammatory and autoimmune disorders, there is no consensus in terms of the best approaches for realizing the clinical applications, which will likely be disease-context dependent. The aim of this timely Research Topic is to therefore create the first unified series capturing all key steps, from inception to manufacturing to clinical application, in a single collection of reviews and mini-reviews, perspectives, methods, and original research articles. By bringing together world-leading experts in the field, we seek to provide a definitive resource for scientists, clinicians, and biotech professionals interested in Treg cell therapy.

This Research Topic accepts Original Research, Systematic Review, Methods, Review and Mini-Review, Clinical Trial, Perspective, Brief Research Report. We welcome manuscripts focusing on, but not limited to, the following sub-topics:

• Choice and sources of Treg: Explore the options of natural vs induced Tregs vs Foxp3-forced expression vs Tr1 cells, and considerations of autologous vs allogeneic approaches.

• Specificity: Investigate target protein or antigen specificity, as well as tissue homing mechanisms.

• Functionality: Assess immunological vs non-immunological functionality, lineage stability, kill switch mechanisms, and signaling pathways.

• Manufacturability: Address critical factors such as expandability, product stability, time, and cost implications in Treg cell production.

• Clinical Trials: Analyze the selection of clinical indications, safety considerations, identification of biomarkers, and potential combination therapies.

Topic Editor Seng-Lai Tan is employed by TFC Therapeutics. Topic Editor Fabien Depis is co-inventor of the following patents: WO2021163064A2, US 2021/0371537 A1, WO2012098238A1, WO2010132872A1. Topic Editor Devan Moodley is employed by Abata Therapeutics, received shared and own stock from Abata Therapeutics.

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Frontiers in Immunology

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