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tolDCcitpep is an investigational autologous cell-based immunotherapy developed by Newcastle University and the Newcastle upon Tyne Hospitals NHS Foundation Trust for the treatment of rheumatoid arthritis (RA). It is an advanced therapy medicinal product (ATMP) consisting of monocyte-derived tolerogenic dendritic cells (TolDC) that are pulsed with a cocktail of synthetic citrullinated peptides representing disease-relevant autoantigens. The therapy is designed to restore immune tolerance by presenting these citrullinated antigens to autoreactive T cells in a non-inflammatory context, thereby suppressing the autoimmune response characteristic of ACPA-positive RA. It is currently being evaluated in the Phase IIa AuToDeCRA-2 trial, which compares various administration routes including intradermal, intra-articular, and intranodal delivery in patients with nil-to-moderate disease activity.
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