<p>Cullinan Therapeutics Inc. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLN-049, a novel FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia (AML). The Fast Track status was granted based on promising efficacy and favorable safety data from a Phase 1 study in heavily pre-treated patients, highlighting the potential of CLN-049 to address a broad population of AML patients with limited treatment options. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cullinan Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9592919-en) on December 01, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

CGEM

<p>Cullinan Therapeutics Inc. has been granted Fast Track designation by the FDA for CLN-049, a FLT3xCD3 T cell engager, aimed at treating relapsed/refractory acute myeloid leukemia (AML). This designation is based on promising Phase 1 study results, indicating potential efficacy and safety for AML patients with limited treatment options.</p>

Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049 in Relapsed/Refractory AML