NCT07455071

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

An Investigator Initiated Clinical Study of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in the Treatment of Patients With HRD-negative Epithelial Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated exploratory study designed to evaluate the safety, tolerability and preliminary efficacy of tumor neoantigen-pulsed autologous dendritic cell injection (YS247) in participants with HRD-negative epithelial ovarian cancer.

Detailed description

A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results

Conditions

• HRD-negative Epithelial Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)	Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-30
• Completion: 2027-11-30
• First posted: 2026-03-06
• Last updated: 2026-03-16