Regulatory T Cell Therapies to Treat Autoimmune Diseases and Transplant Rejection – Challenges & Opportunities

The NIAID-HESI Workshop on Regulatory T Cell Therapies to Treat Autoimmune Diseases and Transplant Rejection – Challenges & Opportunities will take place on November 12-13, 2025, at the NIAID Conference Center in Rockville, MD.

Co-hosted by the National Institute of Allergy and Infectious Diseases (NIAID) and the Health and Environmental Sciences Institute (HESI), this workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to critically assess:

1. Key concepts in Treg biology and associated pharmacological and toxicological potential
2. Lessons learned from non-engineered autologous Treg clinical trials
3. Manufacturing challenges and opportunities
4. How current nonclinical safety evaluation is carried out for engineered regulatory T cell therapies, including understanding both the usefulness and limitations to in vivo and in vitro methodologies currently employed
5. Clinical development challenges and opportunities
6. Regulatory considerations

The full agenda is available here.