Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
Early Phase 1
Not yet recruiting
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: IPM001
- Registration Number
- NCT05105815
- Lead Sponsor
- Huashan Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 23
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IPM001 IPM001 A neoantigen/tumor-specific antigen sensitized autoimmune cell injection
- Primary Outcome Measures
Name Time Method DFS 18 months The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
- Secondary Outcome Measures
Name Time Method OS 24 months From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
EORTC-QLQ30 18 months
Trial Locations
- Locations (1)
Huashan hospital Fudan university
🇨🇳Shanghai, Shanghai, China