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Cullinan Therapeutics, Inc. (CGEM) filed an 8-K current report with the SEC on June 10, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Updated Phase 1 OUTRACE data for CLN-978 in treatment-refractory RA and SLE.
Cullinan Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Updated Phase 1 OUTRACE data for CLN-978 in treatment-refractory RA and SLE
- Initial Phase 1b/2a velinotamig data in treatment-refractory SLE from Genrix’s China trial
- Clinical updates may influence investor views on efficacy, safety, and pipeline value
- Full results and trial details in Exhibit 99.1 press release
Item 8.01 · Other Events
- CLN-978 showed remission in one heavily pretreated RA patient, with DAS28-ESR falling from 4.0 to 2.2 by week four
- Three-patient SLE multi-dose safety data remained favorable, with nephritis observations supporting planned lupus nephritis expansion in early 2027
- Velinotamig produced complete renal responses in both evaluable SLE patients, with SLEDAI-2K scores declining from 16 and 14 to zero and two
- Velinotamig showed no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome in those two patients
- Upcoming catalysts include CLN-978 RA data in Q3 2026, SLE data in Q4 2026, and velinotamig autoimmune cytopenia trial initiation in Q1 2027
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