Cullinan Oncology(US:CGEM) Globenewswire·2025-12-08 15:31Core Insights - CLN-049 monotherapy shows promising efficacy in patients with relapsed/refractory acute myeloid leukemia (R/R AML), achieving a 31% complete response (CR) rate at the highest tested dose of 12 µg/kg [1][5][12] - The drug has received Fast Track designation from the U.S. FDA, indicating its potential to address unmet medical needs in AML treatment [1][12] - An in-person event will be held by the company to discuss the clinical data presented at the 67th American Society of Hematology Annual Meeting [1][8] Efficacy Results - As of August 2025, 45 patients were enrolled in the Phase 1 study, with 41 patients being evaluable for efficacy [3] - The CR/CRh rate at the highest dose of 12 µg/kg was 31%, with anti-leukemic activity observed at doses ≥6 µg/kg [5][6] - Among patients achieving a CR/CRh response at doses ≥6 µg/kg, 63% had a duration of response exceeding 16 weeks [4][6] Safety Profile - The safety profile of CLN-049 is favorable, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%) and infusion-related reactions (33.3%) [13] - Most adverse events were Grade 1 or 2, with no Grade 3 cytokine release syndrome observed [13] Target Population - CLN-049 targets FLT3-expressing leukemia cells, applicable to both mutated and non-mutated forms, making it relevant for a broad population of AML patients [10][13] - The drug shows particular promise for patients with TP53-mutated AML, with a 50% CR/CRh response rate observed in this subgroup at the highest dose [13] Future Development - The development of CLN-049 will continue under FDA Fast Track designation, with ongoing dose escalation and planned expansion cohorts in early 2026 [7][12]