Phase I CARLYSLE study: CAR T-cell therapy obe-cel shows favorable safety and clinical benefit in severe refractory lupus
By
Maria Leandro, Ruth Pepper, Ben Parker, Eleni Tholouli, David Jayne, Ben Uttenthal, Josefina Cortés-Hernández, Pere Barba, José Andrés Román Ivorra, Yanqing Hu, Wolfram Brugger, Silvia Basilico, Davide Germano, Claire Roddie
Summary
This article reports initial results from the phase I CARLYSLE study evaluating obecabtagene autoleucel (obe-cel), a CD19-targeting CAR T-cell therapy, in patients with severe refractory systemic lupus erythematosus (srSLE). As of November 2025, 9 adult patients were infused with either 50×10⁶ or 100×10⁶ CAR T-cells. The therapy demonstrated a favorable safety profile with no neurotoxicity or severe cytokine release syndrome. In the 50M cohort, 83.3% achieved DORIS remission (median onset: 5.1 months), and clinically meaningful reductions in SLEDAI-2K scores were observed in all patients. Robust CAR T-cell expansion and deep B-cell depletion were noted, with B-cell recovery showing predominantly transitional and naïve cells.
Source
bskyPhase I CARLYSLE study: CAR T-cell therapy obe-cel shows favorable safety and clinical benefit in severe refractory lupuslupus.bmj.comKey quotes
· 5 pulledNo immune effector cell-associated neurotoxicity syndrome, or Grade ≥2 cytokine release syndrome events were observed
In the 50M cohort: 5/6 (83.3%) patients achieved DORIS (median onset: 5.1 months)
obe-cel demonstrated a favourable safety profile and clinical benefit despite severe baseline disease activity
All patients showed deep B-cell depletion post-infusion; >90% of reconstituted B-cells at time of recovery (median: 6.0 months) were transitional and naïve
Clinically meaningful reductions in SLEDAI-2K were observed in all patients
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