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

ConditionAdvanced Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years (inclusive)

Radiologically measurable disease per RECIST v1.1

White blood cell count (WBC) ≥3.0 × 10⁹/L

Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L

Disqualifiers

Adequately treated basal cell or squamous cell skin cancer

Carcinoma in situ of the cervix

Detectable HBV DNA (if HBsAg positive or HBcAb positive)

Detectable HCV RNA

Trial design

Design model

Single group

Treatments tested in this trial

  • iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine

    Biological/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.

  • iNeo-Vac-T01 Personalized T Cell Injection

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental group（iNeo-Vac-P01+iNeo-Vac-T01）Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Successful Administration Rate of iNeo-Vac-T01

Proportion of enrolled patients who received the complete planned iNeo-Vac-T01 cell infusion.

Time frame
Up to 3 years
2

Incidence of Adverse Events (AEs)

Incidence of adverse events (AEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including serious adverse events (SAEs) .

Time frame
Up to 3 years

Secondary outcomes

1

Progression-Free Survival (PFS)

Defined as the time from the first administration of iNeo-Vac-P01 to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause (whichever occurs first), or the time from the first administration of iNeo-Vac-T01 to the first documented disease progression per RECIST v1.1 or death from any cause (whichever occurs first). Disease progression is determined by investigator assessment of serial tumor imaging \[Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)\].

Time frame
up to 3 years
2

Objective Response Rate (ORR)

Defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.Disease progression is determined by investigator assessment of serial tumor imaging \[Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)\].

Time frame
up to 3 years
3

Neoantigen-Specific T Cell Response in Peripheral Blood

Vaccine-induced neoantigen-specific CD4⁺ and CD8⁺ T lymphocyte responses detected in peripheral blood using enzyme-linked immunospot (ELISpot) assay .

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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