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FT538 is an investigational, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. It is engineered with three key components for enhanced anti-tumor activity and persistence: - A high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor to improve antibody-dependent cellular cytotoxicity (ADCC) - An IL-15 receptor fusion protein (IL-15RF) to augment NK cell activity - Deletion of the CD38 gene (CD38KO), which increases resistance to oxidative stress and prevents fratricide in the presence of anti-CD38 monoclonal antibodies. FT538 is designed to enhance innate immunity in cancer patients whose endogenous NK cells are often depleted or dysfunctional due to prior treatments or tumor-induced suppression. Preclinical studies have shown that FT538 exhibits superior serial killing capacity and functional persistence compared to peripheral blood NK cells. The drug has been investigated for use as monotherapy and in combination with monoclonal antibodies such as daratumumab for multiple myeloma.
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