Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

MG4101

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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 /㎣
- Total bilirubin < 3.0 ㎎/㎗
- Serum creatinine ≤ 1.5 x upper normal limit (UNL)
- Total Albumin ≥ 2.8 ㎎/㎗
Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion criteria

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.

Sites / Locations

Seoul National University Hospital
Seoul Asan Medical center
Samsung Medical Center
Korea Univ. Guro Hospital
Severance hospital
Ajou Univ. Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

The Control Group

The Treatment Group (MG4101)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time To progression

Secondary Outcome Measures

Progression-free survival

Overall survival

change of Tumor Markers(AFP, Alpha-Fetoprotein)

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

Full Information

NCT ID

NCT02854839

First Posted

July 28, 2016

Last Updated

September 24, 2019

Sponsor

GC Cell Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02854839

Brief Title

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

Official Title

Multi-center, Open, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of MG4101 in Hepatocellular Carcinoma After TACE

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

November 28, 2016 (Actual)

Primary Completion Date

September 27, 2018 (Actual)

Study Completion Date

September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GC Cell Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group). Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date. The Control group's patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.

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

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The Control Group

Arm Type

No Intervention

Arm Description

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.

Arm Title

The Treatment Group (MG4101)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

MG4101

Other Intervention Name(s)

allogeneic natural killer cells

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time To progression

Time Frame

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

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

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

Title

Overall survival

Time Frame

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

Title

change of Tumor Markers(AFP, Alpha-Fetoprotein)

Time Frame

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

Title

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

Time Frame

up tp 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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 /㎣ Total bilirubin < 3.0 ㎎/㎗ Serum creatinine ≤ 1.5 x upper normal limit (UNL) Total Albumin ≥ 2.8 ㎎/㎗ Able and willing to provide written informed consent and to comply with the study protocol. Exclusion criteria 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung Hwan Yoon, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Seoul Asan Medical center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Korea Univ. Guro Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Severance hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Ajou Univ. Hospital

City

Suwon

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs