GlobeNewswire·Jul 28, 2026, 7:00 AM ET

Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML

Cullinan Therapeutics received positive feedback from the U.S. FDA following an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 T cell engager for acute myeloid leukemia (AML).
The company plans to initiate a potentially registrational Phase 2 study for CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026.
The approved Phase 2 study design includes a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose.
Cullinan also plans to start a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, & azacitidine in previously untreated AML patients (NCT07722767).
Updated data from the dose escalation portion of the ongoing Phase 1 study is scheduled to be shared in Q4 2026.
CLN-049 is an investigational bispecific T cell engager designed to target FLT3-expressing leukemia cells regardless of FLT3 mutational status.
The drug has received Orphan Drug & Fast Track designations from the FDA for treating relapsed/refractory AML.
CLN-049 is currently being evaluated in multiple open-label studies assessing safety, tolerability, & efficacy in AML & myelodysplastic syndrome (MDS) patients.