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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Senti Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9599047) on December 09, 2025, and is solely responsible for the information contained therein.
Comments