NCT07324304

NWRD06 DNA Plasmid for HCC After Curative Resection.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD06 in Patients With Hepatocellular Carcinoma After Curative Resection.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Newish Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multi-center Phase 2 clinical study to evaluate the efficacy and safety of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after curative resection.

Detailed description

Eligible subjects will receive three injections of 4 mg NWRD06 at Weeks 0, 4, and 8. All enrolled subjects will be assessed by tumor imaging at Weeks 12, 24, 36, 48, and 72 after the first dose. These assessments will continue until the first occurrence of any of the following: disease recurrence, meeting withdrawal criteria, initiation of new antitumor therapy, or the completion of Week 72.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

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

Timeline

• Start date: 2025-12-08
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

6 sites across 1 country: China