A phase I, single-arm, open-label, dose-escalation, multicenter study of SAR445419, an off-the-shelf, ex vivo expanded allogeneic natural killer cell product, in participants with relapsed or refractory acute myeloid leukemia

Key Points

• To assess the safety of ex vivo expanded allogeneic NK cells in patients with relapsed or refractory acute myeloid leukemia.
• Phase I, single-arm, open-label design
• Participants received off-the-shelf NK cells
• Dose-escalation approach was employed
• Demonstrated overall safety of the NK cell product
• Feasibility of manufacturing and distribution was confirmed
• Further improvements in clinical efficiency are needed