secwatch.observer — SEC 8-K summary
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Issuer:     Cabaletta Bio, Inc. (CABA)
CIK:        0001759138
Form:       8-K
Filed at:   2025-02-18T23:59:59+00:00
Accession:  0001193125-25-028143
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cabaletta Bio: rese-cel shows deepening responses; 3/4 SLE in remission, first LN complete renal response
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- 3 of 4 non-renal SLE patients achieved DORIS remission; first LN patient achieved complete renal response; all 6 SLE/LN patients off immunosuppressants and steroids.
- First dermatomyositis patient maintained major TIS improvement at 3 months off all therapies; IMNM patients showed more gradual improvement.
- First SSc patient showed skin improvements and lung function improvement at 3 months post-infusion off disease-specific therapies.
- Safety: 90% of first 10 patients had no or Grade 1 CRS; 90% had no ICANS. Deep B cell depletion confirmed via lymph node biopsy.
- Enrollment: 50 clinical sites actively recruiting; 26 patients enrolled as of Feb 13, 2025; plan to meet FDA in H1 2025 on registrational design.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525028143/0001193125-25-028143-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525028143/d916444d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-028143

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