secwatch.observer — SEC 8-K summary
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Issuer:     Adicet Bio, Inc. (ACET)
CIK:        0001720580
Form:       8-K
Filed at:   2026-09-28T12:15:31+00:00
Accession:  0001720580-26-000060
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Adicet prula-cel Phase 1: 50% CRR in lupus nephritis at 12 months, 54% DORIS remission; pivotal study to start Q4 2026
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- 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).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720580/000172058026000060/0001720580-26-000060-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720580/000172058026000060/acet-20260928.htm
  HTML page:      https://secwatch.observer/filing/0001720580-26-000060

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer