LBS1:04 DORIS-PLUS: towards a definition of deep remission in lupus

~Day 42 and continuing to at least ~6 months.Reconstituting B cells were initially dominated by a nave phenotype at Day 42, with limited representation of memory/activated subsets across subsequent monthly assessments.Serologically, B-cell elimination was associated with marked, sequential reduction in circulating immunoglobulins with earlier recovery of IgM relative to IgA and IgG during reconstitution consistent with half-live.Anti-dsDNA antibody declined rapidly to undetectable levels and remained suppressed through follow-up; anti-Rubella titers from prior vaccination also remained undetectable.Eighteen pts have reached initial assessment; with a mean follow up of 6 months 100% of pts achieved SRI-4 response, 78% (14/18) achieved LLDAS, 50% (9/18) achieved DORIS remission.Among pts with a follow up >= 6 months, 60% (6/10) achieved DORIS remission.Conclusions CTA313 produces deep, durable B-cell depletion followed by predominantly nave B-cell and immunoglobin repopulation, sustained suppression of pathogenic autoantibodies, and antiviral vaccine titers-an immunologic profile consistent with an immune-reset mechanism that may enable prolonged remission in autoantibody-mediated autoimmune disease.