FDA clears IND application for novel CAR-T to treat advanced acute myeloid leukemia
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The FDA cleared an investigational new drug application for KITE-222, a chimeric antigen receptor T-cell therapy for adults with relapsed or refractory acute myeloid leukemia, according to the agent’s manufacturer.
KITE-222 (Kite Pharma/Gilead) is an autologous, gene-edited CAR T-cell therapy that targets C-type lectin-like molecule-1 (CLL-1), which is expressed by lineage-committed myeloid cells and absent on healthy hematopoietic stem cells.
Kite already has received regulatory approval for two CD19-directed CAR T-cell therapies in the U.S. The FDA approved axicabtagene ciloleucel (Yescarta) in October 2017 for treatment of adults with relapsed or refractory large B-cell lymphoma and brexucabtagene autoleucel (Tecartus) in July 2020 for treatment of adults with relapsed or refractory mantle cell lymphoma.
“The clearance of our IND application for KITE-222 is an important milestone against the ambitious and innovative aims of our CAR-T development program,” Francesco Marincola, MD, senior vice president and global head of cell therapy research at Kite, said in a company-issued press release. “As the leader in cell therapy, Kite has established the industry’s first-ever CAR-T franchise of CD19-targeted therapies and we are broadening our research approach with CLL-1 in AML, where CAR-T development has historically been limited due to the lack of a specific target.”
The IND clearance will allow Kite to begin a first-in-human, phase 1 multicenter study of KITE-222 for adults with relapsed or refractory AML. The study is expected to begin later this year, according to the release.
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