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

NCT05105815 | Unknown Early Phase 1

• 1 other identifier: KY2021-567
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• DFS

  The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause

  18 months

Secondary Outcomes (2)

• OS

  24 months

• EORTC-QLQ30

  18 months

Study Arms (1)

IPM001

EXPERIMENTAL

A neoantigen/tumor-specific antigen sensitized autoimmune cell injection

Biological: IPM001

Interventions

IPM001 BIOLOGICAL

IPM001 will be used against tumor cells

IPM001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huashan Hospital: lead
• Beijing Immupeutics Medicine Technology Limited: collaborator
• Peking University People's Hospital: collaborator

Study Sites (1)

Huashan hospital Fudan university

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hao Zhang, PhD

CONTACT

8613917775888; drhao@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 3, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)