Cullinan’s CLN-978 Drives RA Remission; Velinotamig Yields Complete SLE Renal Responses
CGEM•Cullinan’s CLN-978 Phase 1 multi-dose cohort in refractory RA patients achieved DAS28-ESR remission, dropping from 4.0 to 2.2 by week 4 with deep B cell depletion and favorable safety. Velinotamig induced complete renal responses in two refractory SLE patients, reducing SLEDAI-2K scores from 16/14 to 0/2 by week 8.
1. CLN-978 Phase 1 Multi-Dose Results
Data from the Phase 1 OUTRACE RA trial show two heavily pretreated, poly-refractory rheumatoid arthritis patients achieved DAS28-ESR remission, with scores falling from 4.0 at baseline to 2.2 by week 4 and maintained through week 8. Deep B cell depletion accompanied the clinical remissions, and the safety profile remained favorable, mirroring observations in the initial SLE cohort where rapid proteinuria improvements support a planned lupus nephritis Phase 2a expansion in early 2027.
2. Velinotamig Clinical Activity and Next Steps
In patients with refractory systemic lupus erythematosus, velinotamig dosing (3 µg/kg then 10 µg/kg) delivered marked SLEDAI-2K reductions from 16 and 14 at baseline to 0 and 2 by week 8, culminating in complete renal responses without cytokine release syndrome or neurotoxicity. Additional multi-dose data are slated for Q4 2026, and a Phase 1/2a trial in autoimmune cytopenias is poised to start in Q1 2027.
