CLN-049 - (Florentine)

July 28, 2026: Cullinan Therapeutics, Inc. (NASDAQ: CGEM) reported positive FDA feedback from an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 bispecific T cell engager in development for acute myeloid leukemia (AML). The FDA discussion covered the planned Phase 2 strategy, and Cullinan said it will initiate a potentially registrational Phase 2 study in relapsed/refractory AML in Q3 2026, featuring a short dose-optimization phase with seamless transition to a single-arm cohort at the recommended Phase 2 dose. The company also plans to start a Phase 1/2 combination study of CLN-049 with venetoclax and azacitidine in previously untreated AML (NCT07722767). Cullinan noted CLN-049 showed “promising clinical activity” and a favorable safety profile in relapsed/refractory AML as presented at the 2025 ASH Annual Meeting, and it plans to provide a dose-escalation update in Q4 2026. CLN-049 holds FDA Orphan Drug and Fast Track designations for relapsed/refractory AML.