TR004

TR004 is an autologous, ex-vivo expanded, gut-homing regulatory T-cell (Treg) immunotherapy developed for the treatment of moderate-to-severe Crohn's disease. The manufacturing process involves isolating CD4+CD25+CD127lowCD45RA+ Tregs from the patient's peripheral blood and expanding them in the presence of rapamycin and a retinoic acid receptor alpha (RARα) agonist. Rapamycin is utilized to ensure the phenotypic stability of the Tregs and prevent their conversion into proinflammatory Th17 cells, while the RARα agonist induces high expression of the α4β7 integrin, which directs the cells to home to the gastrointestinal tract. Once infused, these gut-targeted Tregs aim to restore immune homeostasis by suppressing overactive effector T cell responses through mechanisms such as the secretion of inhibitory cytokines (IL-10, TGF-β) and the sequestration of IL-2.

Other names

autologous gut-homing regulatory T cellsTRIBUTE Treg immunotherapy