Advanced Hepatocellular Carcinoma (HCC)Phase 1/2NCT07123545
Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine and iNeo-Vac-T01 Personalized T Cell Injection in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine and iNeo-Vac-T01 Personalized T Cell Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive)
- Histologically confirmed advanced hepatocellular carcinoma (HCC) with:
- <!-- -->
- Radiologically measurable disease per RECIST v1.1
- Documented progression on ≥2 prior lines of systemic therapy 3.Life expectancy ≥6 months 4.ECOG performance status 0 or 1 5.Available archival or fresh tumor tissue sufficient for comprehensive genomic profiling OR existing whole-genome sequencing (WGS), whole-exome sequencing (WES), or RNA-sequencing data meeting prespecified quality thresholds 6.Adequate organ and marrow function:
- (1)Hematologic:
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- White blood cell count (WBC) ≥3.0 × 10⁹/L
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Hemoglobin ≥9.0 g/dL (≥5.6 mmol/L)
- Platelet count ≥100 × 10⁹/L (2)Hepatic:
- a.Total bilirubin ≤1.5 × upper limit of normal (ULN) (≤3 × ULN if liver metastases present) b.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN (≤5 × ULN if liver metastases present) (3)Renal:
- Serum creatinine ≤1.5 × ULN OR
- Calculated creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula) (4)Coagulation:
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- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN AND activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless receiving therapeutic anticoagulation with stable INR/PT/aPTT within target range) 7.Reproductive Status:
- Women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days prior to treatment initiation AND agreement to use highly effective contraception during study participation and for ≥120 days after last study intervention
- Men: Agreement to use barrier contraception during study participation and for ≥120 days after last study intervention 8.Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- 1.History of other active malignancies within the past 5 years, except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Other malignancies considered cured with minimal risk of recurrence (e.g., localized thyroid cancer) 2.Failure to identify therapeutically targetable neoantigens via genomic analysis 3.Prior allogeneic bone marrow, solid organ, or hematopoietic stem cell transplantation 4.Active or symptomatic central nervous system (CNS) metastases except:
- (1)Previously treated CNS metastases that are radiologically stable (no evidence of progression) for ≥4 weeks and (2)Asymptomatic and off corticosteroid/anticonvulsant therapy for ≥4 weeks prior to enrollment (3)Note: Leptomeningeal disease is excluded regardless of stability or treatment status.
- 5.Active bacterial, fungal, or mycobacterial infection requiring systemic therapy (including untreated latent tuberculosis) 6.Active viral infections meeting any of the following:
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- Detectable HBV DNA (if HBsAg positive or HBcAb positive)
- Detectable HCV RNA
- HIV infection (serologically confirmed)
- Active syphilis infection (serologically confirmed) 7.Active autoimmune disease requiring systemic immunosuppressive therapy (>10 mg prednisone equivalent daily) within the past 2 years, except:
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- Vitiligo
- Type 1 diabetes mellitus
- Hypothyroidism stable on hormone replacement
- Psoriasis not requiring systemic therapy 8.Systemic immunosuppressive therapy (>10 mg prednisone equivalent per day) within 14 days prior to planned cell infusion (topical, inhaled, or ophthalmic corticosteroids are permitted) 9.Uncontrolled intercurrent illness including, but not limited to:
- (1)New York Heart Association (NYHA) Class III or IV congestive heart failure (2)Unstable angina pectoris (3)Uncontrolled cardiac arrhythmia (4)Uncontrolled hypertension (≥160/100 mmHg despite medication) (5)Clinically significant pulmonary disease 10.History of substance abuse or psychiatric/social condition that would impair ability to provide informed consent or comply with study requirements 11.History of severe (Grade ≥3) hypersensitivity reactions to vaccine components or investigational products, or any condition deemed by the investigator to pose an unacceptable risk for immunotherapy 12.Any condition that, in the opinion of the Investigator, would compromise patient safety or interfere with study participation or interpretation of results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
yinan shen, +8619941463683, fysyn@163.com
About this study
Official title: Feasibility, Safety and Efficacy Study of Autologous Neoantigen-Specific T-Cell Therapy (iNeo-Vac-T01) in Advanced Hepatocellular Carcinoma Patients
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)
- Being tested
- iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine, iNeo-Vac-T01 Personalized T Cell Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNeo-Vac-P01 Personalized Neoantigen Peptide VaccineBiological
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 InjectionBiological
Administered via intravenous infusion: Dose Level 1: 5×10⁹ to 10×10⁹ cells; Dose Level 2: 1×10¹⁰ to 5×10¹⁰ cells.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group（iNeo-Vac-P01+iNeo-Vac-T01） | Experimental | iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine Route of administration: Subcutaneous injection. Dosage: 0.3 mg per peptide. Administration schedule: Days 1, 4, 8, 15, 22, 52, and 82 (relative to treatment initiation).
iNeo-Vac-T01 Personalized Cell Therapy (initiated at Week 9) Route of administration: Intravenous infusion. Dosing regimen: "3+3" dose escalation design. Dose Level 1: 5 × 10⁹ to 10 × 10⁹ cells. Dose Level 2: 1 × 10¹⁰ to 5 × 10¹⁰ cells.
Lymphodepleting preconditioning regimen: Agents: Cyclophosphamide + Fludarabine. Timing: Administered prior to cell infusion.
Post-infusion supportive therapy: Interleukin-2 (IL-2) support for 10 days. Receives: Biological: iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine; Biological: iNeo-Vac-T01 Personalized T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Administration Rate of iNeo-Vac-T01
Proportion of enrolled patients who received the complete planned iNeo-Vac-T01 cell infusion.
Measured: Up to 3 years
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) .
Measured: Up to 3 years
Secondary outcomes (3)
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)].
Measured: up to 3 years
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)].
Measured: up to 3 years
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 .
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123545
- Sponsor's protocol ID
- ZY-INEO-T01
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Efficacy Study of Autologous Neoantigen-Specific T-Cell Therapy (iNeo-Vac-T01) in Advanced Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT07123545
- Acronym / sponsor ID
- ZY-INEO-T01
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group（iNeo-Vac-P01+iNeo-Vac-T01） | Experimental | Biological: iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine, Biological: iNeo-Vac-T01 Personalized T Cell InjectioniNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine Route of administration: Subcutaneous injection. Dosage: 0.3 mg per peptide. Administration schedule: Days 1, 4, 8, 15, 22, 52, and 82 (relative to treatment initiation). iNeo-Vac-T01 Personalized Cell Therapy (initiated at Week 9) Route of administration: Intravenous infusion. Dosing regimen: "3+3" dose escalation design. Dose Level 1: 5 × 10⁹ to 10 × 10⁹ cells. Dose Level 2: 1 × 10¹⁰ to 5 × 10¹⁰ cells. Lymphodepleting preconditioning regimen: Agents: Cyclophosphamide + Fludarabine. Timing: Administered prior to cell infusion. Post-infusion supportive therapy: Interleukin-2 (IL-2) support for 10 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 to 75 years (inclusive)
- Histologically confirmed advanced hepatocellular carcinoma (HCC) with:
- <!-- -->
- Radiologically measurable disease per RECIST v1.1
- Documented progression on ≥2 prior lines of systemic therapy 3.Life expectancy ≥6 months 4.ECOG performance status 0 or 1 5.Available archival or fresh tumor tissue sufficient for comprehensive genomic profiling OR existing whole-genome sequencing (WGS), whole-exome sequencing (WES), or RNA-sequencing data meeting prespecified quality thresholds 6.Adequate organ and marrow function:
Key exclusion criteria (16 listed)
- (1)Previously treated CNS metastases that are radiologically stable (no evidence of progression) for ≥4 weeks and (2)Asymptomatic and off corticosteroid/anticonvulsant therapy for ≥4 weeks prior to enrollment (3)Note: Leptomeningeal disease is excluded regardless of stability or treatment status.
- 5.Active bacterial, fungal, or mycobacterial infection requiring systemic therapy (including untreated latent tuberculosis) 6.Active viral infections meeting any of the following:
- <!-- -->
- (1)New York Heart Association (NYHA) Class III or IV congestive heart failure (2)Unstable angina pectoris (3)Uncontrolled cardiac arrhythmia (4)Uncontrolled hypertension (≥160/100 mmHg despite medication) (5)Clinically significant pulmonary disease 10.History of substance abuse or psychiatric/social condition that would impair ability to provide informed consent or comply with study requirements 11.History of severe (Grade ≥3) hypersensitivity reactions to vaccine components or investigational products, or any condition deemed by the investigator to pose an unacceptable risk for immunotherapy 12.Any condition that, in the opinion of the Investigator, would compromise patient safety or interfere with study participation or interpretation of results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNeo-Vac-P01 Personalized Neoantigen Peptide VaccineAdministered 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 | Experimental group（iNeo-Vac-P01+iNeo-Vac-T01） |
| iNeo-Vac-T01 Personalized T Cell InjectionAdministered via intravenous infusion: Dose Level 1: 5×10⁹ to 10×10⁹ cells; Dose Level 2: 1×10¹⁰ to 5×10¹⁰ cells. | Biological | Experimental group（iNeo-Vac-P01+iNeo-Vac-T01） |
Primary outcome
Successful Administration Rate of iNeo-Vac-T01
Time frame: Up to 3 years
Proportion of enrolled patients who received the complete planned iNeo-Vac-T01 cell infusion.
Incidence of Adverse Events (AEs)
Time frame: Up to 3 years
Incidence of adverse events (AEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including serious adverse events (SAEs) .
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to 3 years
Objective Response Rate (ORR)
Time frame: up to 3 years
Neoantigen-Specific T Cell Response in Peripheral Blood
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine and iNeo-Vac-T01 Personalized T Cell Injection in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingbo Liang (+8619941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Administration Rate of iNeo-Vac-T01 (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.