{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-114841","form_type":"8-K","ticker":"CGEM","cik":"0001789972","company_name":"Cullinan Therapeutics, Inc.","filed_at":"2024-10-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.642441+00:00","generated_at":"2026-05-30T13:55:24.957754+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Cullinan Therapeutics receives FDA IND clearance for CLN-978 in moderate-to-severe SLE","bullets":["FDA cleared IND for CLN-978, a CD19 T cell engager, in systemic lupus erythematosus.","Phase 1 trial will enroll patients with SLEDAI score ≥8 and inadequate response to ≥2 prior treatments.","Starting dose 10 mcg; Part A dose escalation, Part B dose expansion with multiple schedules.","First development-stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.","Global trial already cleared in Australia (NCT06613360); U.S. enrollment now allowed."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-114841","json":"https://secwatch.observer/filing/0000950170-24-114841.json","markdown":"https://secwatch.observer/filing/0000950170-24-114841.md","text":"https://secwatch.observer/filing/0000950170-24-114841.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1789972/000095017024114841/0000950170-24-114841-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1789972/000095017024114841/cgem-20241016.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T13:55:24.957754+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"}