FC004 / Sun Yat-sen University - LARVOL DELTA

Mesothelin-targeted CAR-T therapy FC004 for platinum-resistant ovarian cancer: A phase I trial (AACR 2025) - "Patients were pre-treated with albumin-bound paclitaxel, cyclophosphamide, and fludarabine, then received a single infusion of FC004. Preliminary results suggest that FC004 CAR-T cell therapy may have limited efficacy in treating platinum-resistant ovarian cancer. One patient achieved SD, while the other experienced significant toxicities, including severe CRS and pulmonary infection. The infection may have been exacerbated by prior high-dose steroids use, but a relationship with FC004 cannot be ruled out."

CAR T-Cell Therapy • IO biomarker • P1 data • Platinum resistant • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • MUC16

Evaluation of clinical safety, tolerability and efficacy of mesothelin-directed chimeric antigen receptor T cells (FC004) in the treatment of recurrent ovarian epithelial cancer (ChiCTR) - P1 | N=3 | Completed | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1 trial • Oncology • Ovarian Cancer • Solid Tumor • MSLN