Clinical trial · Interventional
Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
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
NCT05105815CI-TRIAL-00054853unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPM001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IPM001
- description
- A neoantigen/tumor-specific antigen sensitized autoimmune cell injection
- interventionNames
- Biological: IPM001
Primary outcomes (1)
- measure
- DFS
- timeFrame
- 18 months
- description
- The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
Secondary outcomes (2)
- measure
- OS
- timeFrame
- 24 months
- description
- From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.