Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan"))), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 (EOP1) meeting for CLN-049, a FLT3xCD3 T cell engager being evaluated in patients with acute myeloid leukemia (AML).

The EOP1 meeting focused on the planned Phase 2 development strategy for CLN-049. Based on discussions with the FDA, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026. The study design agreed with the FDA incorporates a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose.