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Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049 at the 67th ASH Meeting

Cullinan Therapeutics (CGEM) | December 8, 2025

By Xander Turner

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Cullinan Therapeutics presented updated clinical data from its Phase 1 study of CLN-049 at the 67th ASH Annual Meeting.

CLN-049 demonstrated promising efficacy in a heavily pretreated all-comer population of patients with relapsed/refractory AML.

The novel FLT3xCD3 bispecific T cell engager showed encouraging response durability and multiple complete responses.

Promising Efficacy

CLN-049 demonstrated a 31% CR/CRh rate at the highest target dose tested, with a favorable safety profile.

Fast Track Designation

CLN-049 was recently granted Fast Track designation by the U.S. FDA, highlighting its potential to aid AML patients.

Novel Therapeutic Approach

CLN-049 targets FLT3, redirecting T cells to eliminate leukemic cells, showing early efficacy and durability benefits.

  • CLN-049 offers hope for expanding treatment options for AML, especially for patients with poor prognosis like those with TP53-mutated AML.
  • The therapy's targeting of FLT3, expressed in over 80% of AML patients, showcases its potential impact on AML treatment outcomes.

The clinical data presented by Cullinan Therapeutics at the ASH Meeting illustrate the potential of CLN-049 to revolutionize AML treatment and provide new hope for patients facing this devastating disease.