{"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","discovered_at":"2026-05-14T18:03:30.334762+00:00","generated_at":"2026-06-10T06:26:33.293727+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Cabaletta Bio receives FDA clearance for third CABA-201 IND, now in systemic sclerosis","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-248186","json":"https://secwatch.observer/filing/0001193125-23-248186.json","markdown":"https://secwatch.observer/filing/0001193125-23-248186.md","text":"https://secwatch.observer/filing/0001193125-23-248186.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T06:26:33.293727+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}