NCT07123545

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
BIOLOGICAL	iNeo-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.
BIOLOGICAL	iNeo-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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-07-31
• Completion: 2029-07-31
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China