Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
IPM001
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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;
Sites / Locations
- Huashan hospital Fudan university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPM001
Arm Description
A neoantigen/tumor-specific antigen sensitized autoimmune cell injection
Outcomes
Primary Outcome Measures
DFS
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
Secondary Outcome Measures
OS
From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
EORTC-QLQ30
Full Information
NCT ID
NCT05105815
First Posted
October 23, 2021
Last Updated
October 23, 2021
Sponsor
Huashan Hospital
Collaborators
Beijing Immupeutics Medicine Technology Limited, Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05105815
Brief Title
Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
Beijing Immupeutics Medicine Technology Limited, Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPM001
Arm Type
Experimental
Arm Description
A neoantigen/tumor-specific antigen sensitized autoimmune cell injection
Intervention Type
Biological
Intervention Name(s)
IPM001
Intervention Description
IPM001 will be used against tumor cells
Primary Outcome Measure Information:
Title
DFS
Description
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
Time Frame
18 months
Secondary Outcome Measure Information:
Title
OS
Description
From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause
Time Frame
24 months
Title
EORTC-QLQ30
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Zhang, PhD
Phone
8613917775888
Email
drhao@hotmail.com
Facility Information:
Facility Name
Huashan hospital Fudan university
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma
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