Phase I Study of FT516, an Off-the-Shelf iPSC-Derived NK Cell Therapy, in Combination with Rituximab in Patients with Relapsed/Refractory B-Cell Lymphoma

Background: Allogeneic natural killer (NK) cell therapies have documented anti-tumor activity in patients with relapsed/refractory (R/R) hematologic malignancies, including B-cell lymphoma (BCL), and may offer an improved safety profile characterized by the absence of cytokine release syndrome (CRS) and neurologic toxicity compared with T-cell therapies (Liu et al. 2020). However, limited availability of suitable donors, relatively short in vivo persistence, and manufacturing constraints limiting the ability to consistently deliver multiple doses remain barriers to maximizing the clinical benefit of NK cell therapy.