CYNK-101 + trastuzumab + pembrolizumab

CYNK-101 + trastuzumab + pembrolizumab is a combination regimen under investigation for the treatment of advanced HER2-positive gastric and gastroesophageal junction (GEJ) adenocarcinoma and consists of three components: CYNK-101 (an allogeneic, genetically modified, off-the-shelf natural killer (NK) cell therapy derived from human placental CD34+ stem cells, engineered to express a high-affinity and cleavage-resistant variant of CD16 (FCGRIIIA) to enhance antibody-dependent cellular cytotoxicity), trastuzumab (a monoclonal antibody targeting HER2), and pembrolizumab (a monoclonal antibody checkpoint inhibitor targeting PD-1)[1][2][5][6]. The combination is designed to harness and potentiate innate NK cell cytotoxicity with CYNK-101, targeted anti-tumor activity via HER2 blockade (trastuzumab), and immune checkpoint inhibition (pembrolizumab), thus synergistically enhancing anti-cancer immune responses. Developed and sponsored by Celularity, this investigational combination had reached phase 1/2a clinical development for first-line use in locally advanced unresectable or metastatic HER2-positive gastric/GEJ cancers, receiving Fast Track and Orphan Drug Designation from the FDA, but the trial was terminated for business reasons as of December 2024[1][2][5][7].

Other names

trastuzumabpembrolizumab