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

Fudan University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Biological: IPM001

Study type

Interventional

Funder types

Other

Identifiers

NCT05105815

KY2021-567

Details and patient eligibility

About

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

Enrollment

23 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;