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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: IPM001

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hao Zhang, PhD; Phone Number: 8613917775888; Email: drhao@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Peking University People's Hospital; Beijing Immupeutics Medicine Technology Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: October 23, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: KY2021-567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No