{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-107011","form_type":"8-K","ticker":"CGEM","cik":"0001789972","company_name":"Cullinan Therapeutics, Inc.","filed_at":"2024-09-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.536210+00:00","generated_at":"2026-05-31T04:18:33.218623+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Cullinan Therapeutics receives Australian HREC approval to start Phase 1 SLE trial of CLN-978","bullets":["HREC approval in Australia to initiate global Phase 1 trial of CLN-978 for systemic lupus erythematosus (SLE).","CLN-978 is a CD19xCD3 bispecific T cell engager designed for off-the-shelf access and convenient dosing.","SLE affects ~430,000 people globally; current treatments rarely induce treatment-free remission.","Company also submitted IND to U.S. FDA for this study on September 16, 2024.","Trial will assess safety, pharmacokinetics, and initial clinical activity in multiple countries."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-107011","json":"https://secwatch.observer/filing/0000950170-24-107011.json","markdown":"https://secwatch.observer/filing/0000950170-24-107011.md","text":"https://secwatch.observer/filing/0000950170-24-107011.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1789972/000095017024107011/0000950170-24-107011-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1789972/000095017024107011/cgem-20240917.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T04:18:33.218623+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"}