secwatch.observer — SEC 8-K summary
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Issuer:     Cabaletta Bio, Inc. (CABA)
CIK:        0001759138
Form:       8-K/A
Filed at:   2025-02-18T23:59:59+00:00
Accession:  0001193125-25-028420
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 reports deepened rese-cel responses: 3 SLE patients in DORIS remission, 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 off immunosuppressants and steroids.
- First adult dermatomyositis patient maintained major TIS improvement at 3 months, off immunosuppressants and tapering steroids.
- Safety: 90% had no CRS or Grade 1 CRS; 90% had no ICANS across first 10 patients dosed with rese-cel.
- Deep B cell depletion within first month; repopulation with naïve phenotype starting ~2 months post-infusion; tissue depletion confirmed by lymph node biopsy.
- 50 clinical sites recruiting in US/Europe; 26 patients enrolled across RESET program as of Feb 13, 2025; average 1 patient/week since November.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525028420/0001193125-25-028420-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1759138/000119312525028420/d925657d8ka.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-028420

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