Cullinan Therapeutics Reports CLN-049 Monotherapy Efficacy With Multiple Complete Responses And Durable Activity In Heavily Pretreated R/R AML Patients, Achieves 31% CR/CRh At Highest Dose, Demonstrates Favorable Safety Across Doses; Phase 1 Data Presented At ASH 2025

CLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML

31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed

CLN-049 recently granted Fast Track designation by the U.S. FDA

Company to host in-person event on Monday, December 8, at 8:00 p.m. ET

CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today shared updated clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). These data will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9, as an oral presentation on Monday, December 8, at 10:45 a.m. ET.