FDA clears IND application for dual-targeting CAR-T to treat advanced lymphoma
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The FDA cleared an investigational new drug application for KITE-363, a chimeric antigen receptor T-cell therapy designed to treat adults with relapsed or refractory large B-cell lymphoma.
KITE-363 (Kite Pharma/Gilead Sciences) is an autologous, gene-edited CAR T-cell therapy that targets both CD19 and CD20 proteins on the surface of cancer cells.
The IND clearance will allow Kite to start enrollment for a clinical trial that will evaluate KITE-363 for patients with relapsed or refractory large B-cell lymphoma. The trial will start with a dose-escalation portion to monitor safety and to determine the appropriate dose for the dose-expansion portion of the study.
The multicenter phase 1 trial should begin by the end of this year, according to a Kite Pharma-issued press release.
The novel cell therapy will become the first dual-targeting CAR-T from Kite to undergo clinical testing. The company already received FDA approval for two CD19-directed CAR T-cell therapies: axicabtagene ciloleucel (Yescarta) for adults with relapsed or refractory follicular lymphoma and large B-cell lymphoma, and brexucabtagene autoleucel (Tecartus) for relapsed or refractory mantle cell lymphoma.
Preclinical testing of KITE-363 “demonstrated robust antigen-specific CAR T-cell function” against both targeted antigens, according to the release.
“CD19-directed CAR T-cell therapies have transformed outcomes for patients with relapsed or refractory large B-cell lymphomas, and we are excited to continue our research on the next generation of potential cell therapy advances,” Francesco Marincola, MD, senior vice president and global head of cell therapy research at Kite, said in the release. “KITE-363 which targets two antigens highly expressed in large B-cell lymphomas, is the next step forward in our research that may improve current treatments to help more patients.”
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