NCT07053072

PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.

A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy

Detailed description

PD-1 mRNA LNP is an immune checkpoint mRNA vaccine loaded with the gene coding for the PD-1 protein Safety, tolerability, immunogenicity and preliminary efficacy of mRNA vaccines with PD-1 as the immunogen in the treatment of primary liver cancer. The aim of this study is to establish a novel PD-1-based mRNA for the treatment of advanced cancers.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	Low Dose PD-1 mRNA LNP Vaccine	Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
DRUG	Medium dose PD-1 mRNA LNP vaccines	Patients will receive PD-1 mRNA LNP vaccine at 75 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
DRUG	High dose PD-1 mRNA LNP vaccines	Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2025-07-08
• Last updated: 2025-12-10

Locations

2 sites across 1 country: China