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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05105815
• Other study ID #: KY2021-567
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 31, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2021
• Source: Huashan Hospital
• Contact: Hao Zhang, PhD
• Phone: 8613917775888
• Email: drhao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• IPM001
IPM001 will be used against tumor cells

Locations

Country	Name	City	State
China	Huashan hospital Fudan university	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Huashan Hospital	Beijing Immupeutics Medicine Technology Limited, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause	18 months
Secondary	OS	From the beginning of NeoAg/aeTSA CTL initiation to the time of death from any cause	24 months
Secondary	EORTC-QLQ30		18 months