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Uncoupled RBCs refer to autologous red blood cells that have been collected from a patient and processed similarly to the therapeutic candidate CLS12311, but without the conjugation of antigenic peptides. Developed by Cellerys AG, these cells are utilized as a control intervention in the RED4MS Phase Ib/IIa clinical trial for patients with relapsing-remitting multiple sclerosis (RRMS). While the lead candidate, CLS12311, consists of red blood cells coupled with peptides representing major MS antigens to induce antigen-specific immune tolerance, the uncoupled RBCs serve to establish a baseline for the safety and biological effects of the cell processing and reinfusion procedure itself. The cells are administered via intravenous infusion and are intended to undergo natural senescence and clearance in the liver and spleen, similar to the active therapy, allowing researchers to isolate the effects of the cell delivery vehicle from the antigen-specific immune modulation.
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