to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Biological: MG4101

Study type: Interventional

Funder types: Other

Identifiers

NCT02008929

HCC_ MG4101

Details and patient eligibility

About

To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

Full description

To see the safety and efficacy of injecting MG4101(Ex vivo expanded allogeneic NK cell) as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

Enrollment: 5 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Under the age of 20 to 69 years of age
2. Child-pugh class A
3. After curative liver resection, diagnosed hepatocellular carcinoma
4. Modified UICC staging : stage 3
5. the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period.
6. Agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing

Exclusion criteria

1. Less than 20 years old, 70 years old or older
2. Metastasis of hepatocellular carcinoma with external parties surgery
3. who had Rupture of hepatocellular carcinoma (HCC)
4. Hepatocellular carcinoma treated with radiofrequency surgery therapeutics (Radiofrequency ablation, RFA), the carotid artery chemical embolization (Transarterial chemoembolization, TACE), underwent radiation therapy, such as topical therapeutics
5. suspected serious infection
6. Who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.)
7. Pregnant, planning a pregnancy or breast-feeding women
8. Autoimmune Disease
9. Those who Latest within four weeks of administration of systemic steroids (However, inhalation, intranasal corticosteroids and topical administration of corticosteroids and short-time administration of a blood transfusion, if such reasons are excluded)
10. Latest within four weeks of taking immunosuppressive drugs such as Cyclosporine A
11. Within the last 5 years diagnosed with liver cancer and other malignancies
12. Investigator did not complete or the effectiveness or safety of pharmaceutical products of this clinical trial evaluation for any medical condition that can interfere with characters judged

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

MG4101

Other group

Description:

Ex vivo expanded allogeneic NK cell

Treatment:

Biological: MG4101