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Trial result

SENTI-202 Logic-Gated CD33/FLT3 CAR-NK Cells Show 44% MRD-Negative CR in First-in-Human AML Study

Cancer type
AML
Published in
New in Oncology - June 6, 2025

SENTI-202 is a ready-made cell therapy that uses natural killer (NK) cells engineered to target cancer in a smart and precise way. It includes an “OR-gate” sensor that activates the cells when they detect either of two cancer markers (CD33 or FLT3), and a “NOT-gate” safety feature that prevents them from attacking healthy cells with the EMCN marker. Additionally, it has a built-in signal (IL-15) that helps the NK cells stay active in the body for a longer time. In the phase I dose-escalation trial (AACR CT014), nine adults with heavily pre-treated relapsed/refractory AML received a single infusion after lymphodepletion: 4 achieved MRD-negative complete remission (44%), one partial response, and two of the CRs bridged to transplant; no grade ≥3 CRS, neurotoxicity, or prolonged cytopenias were reported, with only transient grade 1-2 fevers as common AEs.

https://aacrjournals.org/cancerres/article/85/8_Supplement_2/CT014/762477/Abstract-CT014-First-in-human-multicenter-study-of

Take home

Early but encouraging—if larger cohorts confirm these CR rates with such a clean safety slate, SENTI-202 could usher in a scalable, off-the-shelf cell-therapy option for CD33/FLT3-positive AML where autologous CAR-T has stumbled.

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