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| Name | Class |
|---|---|
| Hangzhou Neoantigen Therapeutics Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNeo-Vac-P01 Personalized Neoantigen Peptide Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Administration Rate of iNeo-Vac-T01 | Proportion of enrolled patients who received the complete planned iNeo-Vac-T01 cell infusion. | 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) . | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. |
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Inclusion Criteria:
(1)Hematologic:
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:
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:
Exclusion Criteria:
1.History of other active malignancies within the past 5 years, 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:
(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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang | Contact | +8619941463683 | liangtingbo@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| iNeo-Vac-T01 Personalized T Cell Injection | Biological | Administered via intravenous infusion: Dose Level 1: 5×10⁹ to 10×10⁹ cells; Dose Level 2: 1×10¹⁰ to 5×10¹⁰ cells. |
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| 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)]. | 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 . | up to 3 years |