Senti Bio announces FDA clearance of IND application for SENTI-202

Senti Biosciences announced that it received clearance of its Investigational New Drug application from the U.S. FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies while sparing healthy bone marrow cells. The company plans to initiate a Phase 1 clinical trial of SENTI-202 in 2024 in multiple sites in the United States and Australia, and expects to treat the first patient in the second quarter of 2024. The dose finding trial will evaluate two dose levels, either 1 or 1.5 billion SENTI-202 cells, administered after lymphodepleting conditioning in adult patients with relapsed or refractory CD33 and/or FLT3 expressing hematologic malignancies, including acute myeloid leukemia. Initial dosing will consist of three doses administered weekly following lymphodepletion, with the option to receive continuation cycles of lymphodepletion and SENTI-202 cells based on safety and efficacy data.