---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-028143"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2025-02-18T23:59:59+00:00"
generated_at: "2026-05-26T17:07:51.490227+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Cabaletta Bio: rese-cel shows deepening responses; 3/4 SLE in remission, first LN complete renal response

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-028143
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2025-02-18T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312525028143/0001193125-25-028143-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312525028143/d916444d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-028143
- JSON: https://secwatch.observer/filing/0001193125-25-028143.json
- Plain text: https://secwatch.observer/filing/0001193125-25-028143.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.