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CLN-049 + azacitidine + venetoclax is an investigational combination regimen being evaluated for the treatment of newly diagnosed acute myeloid leukemia (AML). The regimen combines CLN-049, a novel bispecific T-cell engager targeting both mutated and non-mutated FLT3 and CD3, with the standard-of-care backbone of azacitidine (a hypomethylating agent) and venetoclax (a BCL-2 inhibitor). Developed by Cullinan Therapeutics, this combination is designed to enhance anti-leukemic activity by recruiting T cells to FLT3-expressing leukemia cells while simultaneously inducing apoptosis and epigenetic modifications. It is currently being evaluated in a Phase 1/2 clinical trial (NCT07722767) in patients with previously untreated AML who are unfit for intensive chemotherapy.
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