NCT06088459

NWRD06 DNA Plasmid for HCC After Radical Resection

Phase I Safety and Immunogenicity Study of NWRD06 in Hepatocellular Carcinoma Patients After Radical Resection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Newish Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a dose escalation Phase 1 clinical study to evaluate the safety and immunogenicity of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after radical resection.

Detailed description

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD06 by electroporation in entire study period. The Maximum tolerated dose of NWRD06 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration. Immunologic reactogenicity in blood samples was assessed at week 0, week 2, week 4, week 6, week 8, week 10, week 12. Peripheral blood samples were then collected every 3 months for immunogenicity assessment until disease progression or specific immune response became undetectable or the study was withdrawn for various reasons or ended (whichever occurred first).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	1mg NWRD06 administered by electroporation	DNA plasmid delivered via IM injection + electroporation using TERESA device
BIOLOGICAL	4mg NWRD06 administered by electroporation	DNA plasmid delivered via IM injection + electroporation using TERESA device
BIOLOGICAL	8mg NWRD06 administered by electroporation	DNA plasmid delivered via IM injection + electroporation using TERESA device

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2023-10-18
• Last updated: 2023-10-18

Locations

1 site across 1 country: China