A Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Study Participants With HRD-negative Epithelial Ovarian Cancer

Inclusion criteria

• ✓. Female aged 18-70 years (inclusive of cut-off values); body weight ≥45 kg.
• ✓. Failed to achieve Complete Response (CR) after completion of at least first-line therapy (i.e., surgery and platinum-based chemotherapy), with abnormal CA125 levels or at least one measurable lesion confirmed by imaging assessment.
• ✓. Completed genomic and transcriptomic sequencing of tumor samples, finished the analysis of genetic mutation characteristics and immune characteristics of tumor samples, and is eligible for screening of personalized tumor neoantigens.
• ✓. Laboratory examinations must meet the following criteria: white blood cell count ≥4.0×10⁹/L; absolute lymphocyte count ≥1.0×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥9.0 g/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×Upper Limit of Normal (ULN) (≤5×ULN for patients with concurrent liver metastases); bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert's syndrome); alkaline phosphatase (ALP) ≤2.5×ULN (≤5×ULN for patients with concurrent liver metastases); albumin ≥30 g/L; serum creatinine and/or urea \<1.5 times the normal value; coagulation tests: international normalized ratio (INR) \<1.7 or prolonged prothrombin time (PT) \<4 seconds.
• ✓. 12-lead electrocardiogram (ECG) must meet the following criteria: no severe arrhythmia, QTcF ≤480 ms.
• ✓. Toxic and adverse reactions induced by previous treatments must have recovered to Grade ≤1 (per NCI-CTCAE v5.0), with the exception of stable Grade 2 sensory neuropathy or alopecia (per CTCAE).
• ✓. With patent vascular access and capable of undergoing peripheral blood mononuclear cell (PBMC) collection.
• ✓. Expected survival time \>6 months.

Exclusion criteria