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FDA clears investigational new drug application for CD19-directed CAR-NK therapy NKX019

May 4, 2021

On April 28, 2021, the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application to evaluate NKX019 for relapsed or refractory (R/R) B-cell malignancies.

This decision permits the start of a phase I clinical trial investigating NKX019 for the treatment of patients with R/R B-cell malignancies, such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia.

NKX019 is an allogeneic, CD19-directed chimeric antigen receptor (CAR)-natural killer (NK) cell therapy developed from the peripheral blood of healthy donors. The product undergoes genetic editing to express membrane-bound IL-15, a cytokine central to the survival, proliferation, persistence, and activity of NK cells.

NKX019 offers an off-the-shelf approach to cancer immunotherapy, and the phase I clinical trial is due to commence in the second half of 2021.

  1. Nkarta Therapeutics. Nkarta receives NKX019 IND clearance from U.S. Food and Drug Administration for treatment of relapsed/refractory B cell malignancies. Published Apr 28, 2021. Accessed May 04, 2021.