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On September 30, 2022, KITE-222, an investigational chimeric antigen receptor (CAR) T-cell therapy, was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute myeloid leukemia (AML).1
This autologous CAR T-cell therapy targets C-type lectin-like molecule-1 (CLL-1). While CLL-1 is expressed in lineage-committed myeloid cells in up to 90% of patients with AML, it is not expressed in healthy hematopoietic stem cells.1
A phase I open-label, multicenter trial evaluating the safety of KITE-222 in patients with relapsed/refractory AML is currently enrolling (NCT04789408).
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