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