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materiality 0.75
Adicet prula-cel Phase 1: 50% CRR in lupus nephritis at 12 months, 54% DORIS remission; pivotal study to start Q4 2026
Adicet Bio, Inc.
- 22 efficacy-evaluable patients (16 lupus nephritis, 6 extra-renal SLE) with 6-21 months follow-up; 13 patients had at least 12 months of follow-up.
- At 12 months, 50% of evaluable LN patients achieved a complete renal response and 54% achieved DORIS remission; all 12-month responses ongoing at 12-21 months except 1 patient.
- Safety: no CRS greater than Grade 2, Grade 1/2 CRS in 25%, no DLTs, IEC-HS or ICANS; infections in 54% (Grade 3+ 8.3%); no GvHD; FDA-aligned profile supports outpatient dosing.
- All patients discontinued immunosuppressants and all but one tapered steroids to 5 mg or less prednisone equivalent; 22/22 achieved undetectable CD19+ B cells with naive-dominant reconstitution.
- FDA-aligned single-arm pivotal LN study (inadequate response to 2+ immunosuppressants; primary endpoint CRR at 12 months) start-up in Q4 2026; data updates H1 2027 (SSc) and mid-2027 (LN/SLE).