Senti Biosciences Completes Enrollment in Phase 1 Clinical Trial of SENTI-202 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Core Insights - Senti Biosciences, Inc. has completed enrollment in its Phase 1 clinical trial for SENTI-202, a first-in-class CAR NK cell therapy targeting CD33 and FLT3 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) [1][2][3] - The clinical data presented at the ASH 2025 Annual Meeting showed deep, minimal residual disease (MRD)-negative, durable complete remissions and a favorable safety profile [1][2] - The company is planning to advance SENTI-202 into a pivotal study for R/R AML and is evaluating potential expansions to newly diagnosed AML and pediatric AML, with discussions with the FDA expected in the first half of 2026 [1][3] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][8] - SENTI-202 is designed to selectively target and eliminate hematologic malignancies while sparing healthy bone marrow cells, featuring an OR GATE for activation and a NOT GATE for protection of healthy cells [5] - The therapy has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may facilitate an expedited development and review process [1][6]