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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05105815

Enrollment

Registered

2021-11-03

Start date

2021-12-31

Completion date

2024-12-31

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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

Interventions

BIOLOGICALIPM001

IPM001 will be used against tumor cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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;

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactHao Zhang, PhD

drhao@hotmail.com8613917775888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026