Senti Bio CAR-NK therapy wins RMAT tag in AML

The U.S. FDA has granted regenerative medicine advanced therapy (RMAT) designation to Senti Biosciences’ potential first-in-class Logic Gated off-the-shelf CAR-NK) cell therapy, SENTI-202, currently in development for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia.

“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,” said Timothy Lu, MD, Ph.D., co-founder and CEO of Senti Bio.

The FDA granted the RMAT designation based on data from the company’s ongoing hase 1 clinical trial of SENTI-202 in adult patients with relapsed or refractory (R/R) CD33 and/or FLT3 expressing hematologic malignancies, including AML. Updated clinical data demonstrating SENTI-202's efficacy, safety, and durability in treating R/R AML were presented orally on December 8 at the ASH Annual Meeting 2025.

SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies, such as AML and myelodysplastic syndrome, while sparing healthy bone marrow cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, and cryopreserved to be available off-the-shelf for use as needed.

Earlier this year, the FDA granted orphan drug designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including AML.