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

NCT07123545 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hangzhou Neoantigen Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-07-31
Completion
2029-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123545 on ClinicalTrials.gov