eligibility_summary
Eligibility: Women 18–80 with histologically confirmed epithelial ovarian cancer, relapsed/refractory after 1st-line, ≥1 measurable lesion (RECIST 1.1), mesothelin-positive tumor, KPS ≥80, life expectancy ≥28 wks, adequate organs (ANC ≥1.5×10^9/L, Plt ≥50×10^9/L, Hgb ≥80 g/L, Alb ≥2.5 g/dL, bili ≤1.5×ULN, AST/ALT ≤3×ULN, Cr ≤1.5×ULN), consent and contraception. Exclude: recent other cancers, CNS mets, major thromboembolism/bleeding, immunodeficiency/active HBV/HCV/infection, significant CV disease, pregnancy/lactation, recent trials, or if unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SZ011 CAR-NK, a genetically engineered chimeric antigen receptor natural killer (NK) cell therapy. Mechanism of action: NK cells are modified to express a CAR that binds mesothelin, a surface antigen overexpressed on ovarian epithelial carcinoma. CAR engagement triggers NK-cell activation and cytotoxicity (e.g., perforin/granzyme release and immune effector signaling), leading to targeted lysis of mesothelin-positive tumor cells and potentially augmenting innate NK activity. Targets: mesothelin-expressing ovarian cancer cells, NK-cell activation/cytotoxic pathways. Trial design: single-arm, open-label, early phase 1 dose-escalation (5.0×10^6 to 5.0×10^8 cells, infused every 2 weeks) in relapsed/refractory, mesothelin-positive ovarian epithelial carcinoma.