ADI-212

September 30, 2026: Adicet Bio, Inc. (NASDAQ: ACET) reported 3Q 2026 updates across prula-cel, ADI-212, and its in vivo CAR-T pipeline.

Prula-cel (formerly ADI-001) in SLE with or without lupus nephritis (LN): in the ongoing Phase 1 study, 22 efficacy-evaluable patients had 6-21 months follow-up as of August 28, 2026. At 12 months, 50% of evaluable LN patients achieved complete renal response and 54% achieved DORIS remission. Mean SLEDAI-2K and PGA fell rapidly and durably; all patients stopped immunosuppressants, and all but one reduced steroids to 5 mg/day prednisone equivalent or less. Safety was favorable, with no Grade >2 CRS, no ICANS, no IEC-HS, and no GvHD. Biomarkers showed complete CD19+ B-cell depletion, naïve-dominant B-cell reconstitution, lower anti-dsDNA antibodies, and complement recovery. A pivotal single-arm LN study is in startup, with FDA discussion planned in 4Q 2026 on possible expansion into lupus without nephritis; a regulatory update plus ~22-patient 12-month follow-up is expected in 1Q 2027. Phase 1 systemic sclerosis data are expected in 2Q 2027.

ADI-212 in mCRPC: FDA cleared the IND in August 2026 and granted Fast Track in September 2026; Phase 1 startup is underway, with enrollment expected in 1Q 2027.

In vivo CAR-T: preclinical programs target multiple myeloma, non-Hodgkin’s lymphoma, and solid tumors; first clinical entry is planned for 2H 2027.