Actively Recruiting
Feasibility, Safety and Efficacy Study of Autologous Neoantigen-Specific T-Cell Therapy in Advanced Hepatocellular Carcinoma Patients
Led by Zhejiang University · Updated on 2025-08-14
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an autologous neoantigen-specific T-cell therapy called iNeo-Vac-T01 for patients with advanced hepatocellular carcinoma who have not responded to two or more prior systemic treatments. This open-label, single-arm phase I/II trial aims to assess the feasibility, safety, and anti-tumor effects of this personalized immunotherapy approach in this patient population. The study is sponsored by Zhejiang University and focuses on advanced cancer that is measurable by imaging and has progressed despite previous therapies. Participants receive a personalized neoantigen peptide vaccine (iNeo-Vac-P01) given by subcutaneous injection on Days 1, 4, 8, 15, 22, 52, and 82, followed by booster shots every 2 to 3 months. Starting at Week 9, patients undergo intravenous infusion of the personalized T cell therapy (iNeo-Vac-T01) using a dose escalation design. Before this infusion, a lymphodepleting regimen with cyclophosphamide and fludarabine is administered. After infusion, supportive therapy with interleukin-2 is given for 10 days to support immune response. During the study, participants will have regular visits for treatment administration and monitoring for up to three years. Researchers will evaluate the success of administering iNeo-Vac-T01 and monitor for adverse events. Secondary measures include progression-free survival, tumor response rates, and immune response in the blood. Patients will undergo laboratory tests, imaging scans, and genomic profiling of tumor tissue to support treatment planning and safety assessments. The total participation duration may last several years as patients are followed for clinical outcomes and safety.
CONDITIONS
Brief Title
Autologous Neoantigen-Specific T-Cell Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years (inclusive)
- Histologically confirmed advanced hepatocellular carcinoma with measurable disease per RECIST v1.1
- Documented progression on two or more prior lines of systemic therapy
- Life expectancy of at least 6 months
- ECOG performance status of 0 or 1
- Available tumor tissue or genomic sequencing data suitable for analysis
- Adequate hematologic, hepatic, renal, and coagulation function
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Men must agree to use barrier contraception
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- History of other active cancers within 5 years except certain treated skin or thyroid cancers
- Inability to identify targetable neoantigens from genomic analysis
- Prior allogeneic bone marrow, solid organ, or stem cell transplantation
- Active or symptomatic central nervous system metastases, except stable treated cases
- Active infections requiring systemic therapy, including untreated latent tuberculosis
- Active viral infections such as hepatitis B, hepatitis C, HIV, or syphilis
- Active autoimmune disease requiring significant immunosuppression, except specified exceptions
- Recent systemic immunosuppressive therapy within 14 days prior to cell infusion
- Uncontrolled serious medical conditions including severe heart failure, unstable angina, severe arrhythmias, uncontrolled hypertension, or significant lung disease
- History of substance abuse or psychiatric conditions impairing consent or compliance
- History of severe allergic reactions to vaccines or study products
- Any condition posing unacceptable risk or interfering with study participation per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months for initial vaccination and cell infusion, followed by booster immunizations every 2 to 3 months
Participants receive a personalized neoantigen peptide vaccine administered subcutaneously on Days 1, 4, 8, 15, 22, 52, and 82, followed by booster immunizations every 2 to 3 months. After initial vaccination, participants receive personalized T cell injections via intravenous infusion starting at Week 9, preceded by lymphodepleting preconditioning, and followed by 10 days of supportive therapy.
Multiple visits including 7 vaccination visits in the first 12 weeks, cell infusion at Week 9, and supportive therapy visits
Duration - Up to 3 years
Participants are monitored for safety, efficacy, and immune response after completing treatment.
Periodic visits for up to 3 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
T
Tingbo Liang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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