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

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early anti-tumor effects of dual-targeting chimeric antigen receptor natural killer CAR-NK cells in women with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. This Phase 12 study assigns participants to CAR-NK products based on their tumors expression of Mesothelin MSLN, Folate Receptor alpha FRalphaFOLR1, and MUC16 CA 125 to target two of these proteins and reduce the risk of tumor escape. The trial aims to find safe doses and explore preliminary effectiveness and biological markers. The study has two parts dose escalation to determine safe dosing levels using a 33 design within antigen-specific groups, followed by dose expansion at the recommended dose. Before treatment, participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. CAR-NK cells are then administered, mainly into the abdominal cavity via an implanted port, with optional intravenous dosing. Participants receive supportive care as needed and are monitored closely for side effects such as immune reactions and infections. Participants undergo tumor assessments using imaging criteria RECIST v1.1 and blood markers like CA 125 at regular intervals. Safety is tracked for 12 months, and survival for up to 24 months, with potential long-term follow-up due to gene therapy regulations. The study includes frequent evaluations of adverse events and treatment responses. Participants are followed closely throughout the study and after treatment to monitor outcomes and safety.

Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2