---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-248186"
form_type: "8-K"
ticker: "CABA"
cik: "0001759138"
company_name: "Cabaletta Bio, Inc."
filed_at: "2023-10-02T23:59:59+00:00"
generated_at: "2026-06-10T06:26:33.293727+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Cabaletta Bio receives FDA clearance for third CABA-201 IND, now in systemic sclerosis

## Summary
- Third IND clearance for CABA-201 (CD19-CAR T) in systemic sclerosis within past 6 months.
- Phase 1/2 trial to enroll two parallel cohorts: severe skin (n=6) and severe organ involvement (n=6).
- Starting dose 1×10^6 cells/kg, same as lupus and myositis trials; three-month data expected by H1 2024.
- SSc affects ~88,000 US patients; average survival ~12 years after diagnosis with limited treatments.
- Trial part of CARTA strategy aiming to reset immune system via transient B-cell elimination.

## SEC filing metadata
- accession: 0001193125-23-248186
- form_type: 8-K
- ticker: CABA
- cik: 0001759138
- company_name: Cabaletta Bio, Inc.
- filed_at: 2023-10-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1759138/000119312523248186/0001193125-23-248186-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1759138/000119312523248186/d513135d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-248186
- JSON: https://secwatch.observer/filing/0001193125-23-248186.json
- Plain text: https://secwatch.observer/filing/0001193125-23-248186.txt

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