GlobeNewswire·Nov 8, 2026, 10:30 AM ET

Velinotamig, a BCMAxCD3 T Cell Engager, Achieves Complete Renal Responses and Significantly Reduces Disease Activity in Systemic Lupus Erythematosus in Data Presented at ACR Convergence 2026

CGEM

Cullinan Therapeutics announced interim clinical data from the Genrix Bio Phase 1b/2a study of velinotamig (GR1803) in patients with refractory systemic lupus erythematosus (SLE).
As of the September 8, 2026 data cutoff, 12 patients had been treated across three multi-dose cohorts.
Eight of nine evaluable patients with at least four weeks of follow-up achieved a clinically meaningful reduction of at least four points in SLEDAI-2K scores.
Among seven evaluable patients with baseline proteinuria greater than 500 mg/24 hours, five experienced rapid \& marked reductions, with four achieving complete renal responses (proteinuria below 500 mg/24 hours) within 24 weeks.
The treatment demonstrated deep \& sustained reductions in pathogenic autoantibodies, IgG, anti-double-stranded DNA antibodies, \& CD19-positive B cells, alongside improvements in complement C3 levels.
Velinotamig showed a favorable safety profile with no dose-limiting toxicities, no immune effector cell-associated neurotoxicity (ICANS), \& no Grade 3 or higher cytokine release syndrome (CRS).
CRS events were limited to Grade 1 or 2 in two patients \& resolved with standard management; no Grade 2 events occurred after step-up dosing regimen modifications.
Velinotamig is a BCMAxCD3 T cell engager designed to target pathogenic autoantibody-producing plasma cells.
The open-label, multicenter study (NCT07348055) evaluates four intravenous doses on Days 1, 4, 8, \& 29 with follow-up up to 48 weeks.
Cullinan Therapeutics holds a global exclusive license to velinotamig from Genrix Bio \& is also evaluating the drug in a separate Phase 1b/2a study for immune thrombocytopenia \& warm autoimmune hemolytic anemia.

Company: Cullinan Therapeutics, Inc.
Keywords: Nasdaq:CGEM, Cullinan Therapeutics, Inc.