First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers.

A statistically significant difference was observed for IMCY-0098 dose B and dose C vs placebo for the change in CD4 + terminal effector cells ( p < 0.001 and p = 0.047, respectively); differences did not reach statistical significance for central memory or effector memory CD4 + cells or for CD4 + cells overall (Fig. 4 B).

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