Adicet Bio: 100% renal response in Phase 1 ADI-001 lupus nephritis; plans FDA meeting Q1 2026

Adicet Bio, Inc.

Seven patients (5 LN, 2 SLE) dosed; follow-up 2–9 months as of Aug 31, 2025 cut-off.
All 5 LN patients achieved renal response: 3 complete, 2 partial; all ongoing; 3 also DORIS remission.
No serious AEs, no ICANS; only Grade 1 CRS (2 patients) and 1 Grade 1 infection; outpatient potential.
All patients discontinued immunosuppressants; discontinued or tapered corticosteroids to physiological levels.
Plans to request FDA meeting in Q1 2026 for pivotal Phase 2 trial design; enrollment continues until study opens.

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