MT-304 + nivolumab

MT-304 + nivolumab is an investigational combination therapy being evaluated for the treatment of advanced HER2-expressing solid tumors. MT-304 is a first-in-class, in vivo chimeric antigen receptor (CAR) therapeutic delivered via an mRNA-lipid nanoparticle (LNP) platform. It is designed to program myeloid and natural killer (NK) cells within the body to express a CAR that targets HER2-positive cancer cells. Nivolumab is a monoclonal antibody that acts as a programmed death-1 (PD-1) immune checkpoint inhibitor, enhancing T-cell anti-tumor activity by blocking the interaction between PD-1 and its ligands. By combining MT-304's direct programming of innate immune cells with nivolumab's adaptive immune checkpoint blockade, the regimen aims to provide a synergistic, multi-pronged immune attack against HER2-expressing malignancies. The combination is currently under investigation in a Phase 1 dose-escalation study sponsored by Myeloid Therapeutics (now Create Medicines).