Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma

Study Overview
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Brief Summary
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In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection

Official Title
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An Exploratory Study on the Safety and Effectiveness of Autoimmune Cell Therapy Sensitized With Liver Cancer Neoantigen in Patients With High Risk of Recurrence After Surgical Resection of Primary Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: IPM001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: understand and voluntarily sign a written informed consent; Age: from 18 to 75 years, No restriction on gender; Patients must have primary hepatocellular carcinoma; Clinical stage: stage Ia III a; Child-pugh score ≤7; HLA-A02 and consistent with ≥1 NeoAg or ≥2 aeTSA peptide bank; ECOG PS score: 0 2; Laboratory values as follow: White blood cell count ≥ 3×109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 85g/L; Platelets: more than 5 × 1010/L; Total bilirubin:≤2 × ULN; Serum AST(GOT) and ALT(GPT)≤2.5 × ULN; Albumin ≥3.0 g/dL (30 g/L); Serum creatinine: less than 1.5 × ULN; Coagulation time was basically normal, PT extension ≤4s; No serious cardiopulmonary disease; Blood collection body weight: male > 50 kg, female > 45 kg; No obvious hereditary diseases; Expected survival: more than 6 months; Exclusion Criteria: Patient has known distant organ metastasis; Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.; Woman be pregnant or lactating; Suffer from mental or neurological diseases that are resistant to control; The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.); Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis); Patients with a history of other malignant tumors in the past 5 years; Organ transplantation or Myelosuppression; History of drug abuse or alcohol abuse;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPM001<br>A neoantigen/tumor-specific antigen sensitized autoimmune cell injection | Biological: IPM001<br>* IPM001 will be used against tumor cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause | 24 months | 
| EORTC-QLQ30 |  | 18 months |