Senti Biosciences Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the company's investigational off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy, for the treatment of relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML). The RMAT designation was based on data from Senti Bio's ongoing Phase 1 clinical trial in adult patients with relapsed or refractory CD33 and/or FLT3 expressing hematologic malignancies. Updated clinical data from this trial were presented orally and in poster form at the American Society of Hematology $(ASH)$ Annual Meeting on December 8, 2025. The results showed a 50% overall response rate and a 42% complete remission or complete remission with partial hematologic recovery at the recommended Phase 2 dose, with a median duration of composite complete remission of 7.6 months across all patients. SENTI-202 has also received Orphan Drug Designation from the FDA earlier in June 2025.