FDA clears IND application for CAR-natural killer cell therapy to treat B-cell malignancies

The FDA cleared an investigational new drug application for NKX019, a chimeric antigen receptor-natural killer cell therapy for patients with relapsed or refractory B-cell malignancies, according to the agent’s manufacturer.

NKX019 (Nkarta) is an allogeneic, gene-edited CAR-natural killer (NK) cell therapy that targets the CD19 protein on the surface of cancer cells.

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The therapy — derived from the peripheral blood of healthy donors — includes Nkarta’s propriety membrane-bound interleukin-15 activation cytokine to promote NK cell growth and enhanced CAR-NK cell persistence.

The IND clearance will allow Nkarta to begin enrollment of a phase 1 clinical trial that will evaluate NKX019 for patients with relapsed or refractory B-cell malignancies, including non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia. The study is scheduled to begin in the second half of this year.

“Academic studies have highlighted the ability of donor-derived NK cells, when collected from healthy donors, to effectively target and kill cancer cells without some of the safety risks commonly associated with T-cell therapies,” Kanya Rajangam, MD, PhD, chief medical officer of Nkarta, said in a company-issued press release. “We look forward to evaluating NKX019 in our trial as a planned multidose, multicycle treatment regimen to determine its potential for enhanced antitumor activity with a beneficial safety profile.”

Nkarta is conducting a multicenter phase 1 trial of NKX101, an allogeneic, gene-edited CAR-NK cell therapy that targets NKG2D ligands expressed by cancer cells. That trial includes adults with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.