SNTI News & Events

Senti Biosciences announced the completion of enrollment in its Phase 1 clinical trial evaluating SENTI-202, a first-in-class CD33/FLT3-targeting Logic Gated CAR NK cell therapy, in patients with relapsed or refractory acute myeloid leukemia. "The completion of enrollment in our Phase 1 trial represents a significant clinical milestone for our SENTI-202 program," said Kanya Rajangam, M.D., Ph.D. Chief Medical Officer at Senti Bio. "Importantly, the encouraging clinical data from this study provide a strong foundation as we actively design our pivotal program for SENTI-202 in AML, as well as potential indication expansion and later-stage clinical development. We look forward to having productive discussions and working closely with the FDA in the first half of this year to discuss the next phase of development for our RMAT-designated program."

Senti Biosciences announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to SENTI-202, the Company's potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer, CAR-NK, investigational cell therapy, that is currently in development for the treatment of relapsed/refractory hematologic malignancies, including AML. "This significant FDA designation validates both the tremendous need for better treatments for R/R AML and the promise of SENTI-202 to transform the therapeutic landscape for this notoriously aggressive cancer," Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. "We are incredibly pleased with the exciting clinical progress we recently shared at the ASH conference on SENTI-202."

Senti Biosciences announced new data from its ongoing multinational, multicenter clinical trial of SENTI-202, a first-in-class CD33/FLT3 targeting Logic Gated CAR NK cell therapy being studied in patients with relapsed or refractory Acute Myeloid Leukemia. Data from 20 patients were presented at the American Society of Hematology, ASH, Annual Meeting in Orlando. Key highlights: ASH 2025 oral presentation on SENTI-202 in 20 Relapsed/Refractory Acute Myeloid Leukemia patients shows high efficacy: 50% ORR and 42% CR/CRh at RP2D, 7.6 months median duration of composite Complete Remission across all patients, and a favorable safety profile; Pharmacodynamic data from these patients validate SENTI-202's novel OR/NOT Logic Gate mechanism of action for selectively killing AML blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells and reinforce the potential of Senti's Logic Gates in a new generation of precise and effective cell therapies for hematologic and solid cancers; These data, combined with FDA RMAT designation for SENTI-202 that was also announced today, supports the potential for rapid advancement of SENTI-202 into a pivotal study for R/R AML and potential expansion into other indications