All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact

KITE-222 granted orphan drug designation by the FDA

Oct 4, 2022
Learning objective: After reading this article, learners will be able to cite a new development in the treatment of AML.

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).

  1. Kite Pharma. Kite receives U.S. Food and Drug Administration (FDA) orphan drug designation for KITE-222 for acute myeloid leukemia. Published Sep 30, 2022. Accessed Oct 4, 2022