Short answer
Cullinan Therapeutics, Inc. (CGEM) filed an 8-K current report with the SEC on June 8, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Initial Phase 1 OUTRACE data for CLN-978 presented in treatment-refractory rheumatoid arthritis and systemic lupus erythematosus.
Cullinan Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Initial Phase 1 OUTRACE data for CLN-978 presented in treatment-refractory rheumatoid arthritis and systemic lupus erythematosus
- Clinical update delivered at EULAR, increasing visibility with rheumatology specialists and investors
- Results are furnished in Exhibit 99.1 and represent an early clinical readout for CLN-978 rug.
Item 8.01 · Other Events
- Phase 1 CLN-978 data showed clinical activity in refractory SLE and RA, supporting potential B-cell depletion across autoimmune diseases
- SLE: 10 of 14 patients achieved ≥4-point hSLEDAI reduction, with 5 reaching DORIS remission after ≥4 weeks
- RA: 5 of 7 patients improved, including one DAS28-ESR remission at the 30 µg target dose
- B-cell depletion below quantification at ≥20 µg doses: 50% of SLE patients and 67% of RA patients
- Safety generally favorable at 10–30 µg, but Grade 3 CRS at 45 µg halted that cohort and may require additional step-up dosing
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