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CLN-049 is a humanized bispecific antibody designed to engage T cells for the treatment of relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It simultaneously binds to fms-like tyrosine kinase 3 (FLT3) on leukemic cells and CD3 on T cells, redirecting cytotoxic T lymphocytes to kill FLT3-expressing malignant cells. The antibody is based on an IgG1 backbone with a silenced Fc domain, minimizing immunogenicity and effector function. Unlike FLT3 tyrosine kinase inhibitors that only target mutant FLT3, CLN-049 targets both wild-type and mutant forms of FLT3, potentially broadening its applicability across AML patients regardless of mutational status. Preclinical studies have shown potent activity in eliminating patient-derived AML blasts in vitro and in mouse models[1][2][5][6][8]. The drug is administered intravenously or subcutaneously[7]. Developed by Cullinan Therapeutics, it is currently being evaluated in Phase 1 clinical trials for relapsed/refractory AML and MDS[4][7].
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