Phase 12 Study of Dual-Targeting CAR-NK Cells for Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Targeting Mesothelin, Folate Receptor Alpha, and MUC16

What this Trial Is About

Researchers are evaluating dual-targeting chimeric antigen receptor natural killer CAR-NK cells for participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. This Phase 12 study aims to assess the safety, tolerability, and early anti-tumor activity of CAR-NK cells matched to the tumors expression of Mesothelin, Folate Receptor alpha, and MUC16 to reduce antigen escape. The study is sponsored by Beijing Biotech and involves biomarker assignment to guide treatment selection. The study has two parts dose escalation using a 33 design to identify a recommended Phase 2 dose, followed by dose expansion to explore efficacy and biomarkers. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, then CAR-NK cells administered mainly intraperitoneally via an implanted port, with optional intravenous dosing. Three CAR-NK products target different pairs of tumor antigens MSLNFRalpha, MSLNMUC16, or FRalphaMUC16, assigned based on tumor antigen expression. Participants undergo tumor tissue testing for target expression and are monitored closely for side effects such as cytokine release syndrome, neurotoxicity, infections, and blood count changes. Disease response is assessed regularly using RECIST criteria and CA 125 tumor marker trends. Safety is followed for 12 months, and survival is tracked for up to 24 months, with possible long-term monitoring for gene-modified cell therapy safety. The study includes various laboratory tests and clinical evaluations throughout participation.

Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)