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A bispecific CD3×CD19 antibody for systemic lupus erythematosus: a phase 1 trial

Nature Medicine (2026; 32:3372-3384)

Early-phase studies of deep B cell depletion with anti-CD19 chimeric antigen receptor (CAR) T have produced prolonged, drug-free remission in refractory autoimmune disease. Here we report results from the intravenous treatment arm of an ongoing, first-in-disease, phase 1 trial of A-319, a next-generation CD3×CD19 TCE, in 12 patients with active systemic lupus erythematosus (SLE) with 52 weeks of follow-up. Patients received A-319 (0.3−1.2 μg kg−1) three times weekly for 3 weeks after 1 week of priming doses (0.05 μg kg−1).

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A bispecific CD3×CD19 antibody for systemic lupus erythematosus: a phase 1 trial