A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma

NCT02854839 | Completed Phase 2

• 1 other identifier: MG4101-HCC-P2a
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 6

Brief Summary

The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time To progression

  every 12 weeks, up to the time of death or 18 months

Secondary Outcomes (4)

• Progression-free survival

  every 12 weeks, up to the time of death or tumor progression, up to 18 months

• Overall survival

  every 12 weeks, up to the time of death, up to 18 months

• change of Tumor Markers(AFP, Alpha-Fetoprotein)

  every 12 weeks, up to the time of death or tumor progression, up to 18 months

• Safety of MG4101 as evaluated by Incidence of adverse events (AEs), serious adverse events (SAEs)

  up tp 9 weeks

Study Arms (2)

The Control Group

NO INTERVENTION

Patients will be randomized 1:1 to the control group and the treatment group. Patients who had allocated control group will not receive adjuvant treatment.

The Treatment Group (MG4101)

EXPERIMENTAL

Patients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7.

Biological: MG4101

Interventions

MG4101 BIOLOGICAL

MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.

Also known as: allogeneic natural killer cells

The Treatment Group (MG4101)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are between 20 to 80 years of age
• Life expectancy \> 12 weeks
• Patients have complete remission according to the mRECIST by Dynamic contrast-enhanced 3- or 4-phase CT or tissue biopsy
• Patients were diagnosed Hepatocellular Carcinoma BCLC stage B be-fore TACE.
• Dynamic contrast-enhanced CT must be within 4 weeks after the TACE.
• Previous TACE with the following:
• Lipiodol mixed with chemotherapy (such as adriamycin etc.)
• Used with Gelatin sponge or Polyvinyl alcohol or microsphere.
• Patients who had local treatment such as Resection, Radiofrequency Ablation, Percutaneous ethanol injection and Transarterial chemoembolization can participates study.
• Patients whose Child-Pugh score is less than B8.
• Patients whose ECOG score is 0
• Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test.
• Absolute neutrophil count ≥ 1,000 x 10\^6 /L
• hemoglobin level ≥ 8.5 g/㎗
• platelet count ≥ 50,000 /㎣

You may not qualify if:

• Patients who have metastasis.
• Patients who have Portal vein or hepatic vein invasion.
• Patient with medical history for the following:
• Patients with Living donor Liver Transplantation or Orthotopic liver transplantation.
• Patients who have received anti-cancer chemotherapy for 4 weeks prior to the study.
• Patients who have not recovered adverse reaction prior to the study.
• Patients who have received external beam radiation on liver, immunotherapy, cell therapy, and target therapy.
• Prior use of systemic anticancer chemotherapy twice.
• Patients who have a history of malignant tumors in 5 years prior to the study with the exception of Carcinoma in situ..
• Patients who have a history of autoimmune disease such as Rheuma-toid arthritis, systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-dependent Diabetes Mellitus, etc.
• Patients who have history of human immunodeficiency virus (HIV) infection.
• Patients who have participated in other clinical trials within 4 weeks prior to this study.
• Patients who treated with immunosuppressant for 3 months prior to this study.
• Patients who have any condition that was uncontrolled or needed treatment.
• Pregnant or breast-feeding subjects.

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (6)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Seoul Asan Medical center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Korea Univ. Guro Hospital

Seoul, South Korea

Location

Severance hospital

Seoul, South Korea

Location

Ajou Univ. Hospital

Suwon, South Korea

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

Study Officials

• Jung Hwan Yoon, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 4, 2016
• Study Start: November 28, 2016
• Primary Completion: September 27, 2018
• Study Completion: September 17, 2019
• Last Updated: September 26, 2019

Record last verified: 2018-10

Locations

KR (6)