Fig. 2: Pipeline for the development of antigen-specific Tregs for autoimmune disease.
From: Smith-specific regulatory T cells halt the progression of lupus nephritis
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.
