RecruitingPhase 1Phase 2NCT07123545

Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma

Feasibility, Safety and Efficacy Study of Autologous Neoantigen-Specific T-Cell Therapy (iNeo-Vac-T01) in Advanced Hepatocellular Carcinoma Patients


Sponsor

Zhejiang University

Enrollment

20 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this open-label, single-arm phase I/II clinical trial is to evaluate the feasibility, safety, and anti-tumor efficacy of the autologous neoantigen-specific T-cell therapy (iNeo-Vac-T01) in patients with advanced hepatocellular carcinoma who have failed second-line or later systemic therapies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized immune cell therapy made from a patient's own tumor-fighting T cells, designed to target specific mutations in the patient's liver cancer (hepatocellular carcinoma, HCC) that has progressed despite prior treatments. **You may be eligible if...** - You are 18–75 years old - You have advanced liver cancer (HCC) confirmed by biopsy - Your cancer has gotten worse after at least 2 prior systemic treatments - Your cancer can be measured on imaging scans - Your life expectancy is at least 6 months - Your overall health is reasonably good **You may NOT be eligible if...** - Your liver cancer has spread to the brain - Your liver function is severely impaired - You have active autoimmune disease - You have had a prior organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALiNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine

Administered subcutaneously at 0.3 mg/peptide on Days 1, 4, 8, 15, 22, 52, and 82, followed by booster immunizations every 2-3 months.

BIOLOGICALiNeo-Vac-T01 Personalized T Cell Injection

Administered via intravenous infusion: Dose Level 1: 5×10⁹ to 10×10⁹ cells; Dose Level 2: 1×10¹⁰ to 5×10¹⁰ cells.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07123545


Related Trials