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Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor (MG4101)

This study has been completed.
Green Cross Corporation
Information provided by:
Seoul National University Hospital Identifier:
First received: September 18, 2010
Last updated: August 15, 2013
Last verified: August 2013
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.

Condition Intervention Phase
Malignant Lymphomas Solid Tumors Biological: Allogeneic NK cells Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • To determine the MTD of allogenetic NK cells [ Time Frame: 4-5 weeks ]

    DLT is defined as follows:

    • Any toxicity at grade 3 or over for 5 days or more
    • All grade 4 toxicities
    • GVHD at grade 2 or over

Secondary Outcome Measures:
  • To determine the overall response rate [ Time Frame: 4-5 weeks ]
    RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma

  • To evaluate the safety [ Time Frame: 4 -5 weeks ]
    NCI-CTCAE v3.0

  • To evaluate the pharmacokinetics of allogeneic NK cells [ Time Frame: 4-5 weeks ]
    To quantify the persistence of donor NK cells in recipients

Estimated Enrollment: 18
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Singe-dose infusion
Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg
Biological: Allogeneic NK cells
Experimental: Repeated dose infusion
Cohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg
Biological: Allogeneic NK cells


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • Histologically or cytologically confirmed malignant lymphoma or solid tumor
  • After the failure of standard treatment
  • KPS >70 or ECOG PS 0-2
  • Adequate bone marrow, renal, and liver functions
  • Expected survival at least 3 months
  • Informed consent

Exclusion Criteria:

  • Pregnancy or lactating woman
  • HIV patients
  • Prior exposure to cell-based therapy
  • Hypersensitivity to interleukin-2
  • Patients with autoimmune disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT01212341

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Green Cross Corporation
  More Information

Responsible Party: Tae Min Kim/Assistant Professor, Seoul National University Hospital Identifier: NCT01212341     History of Changes
Other Study ID Numbers: MG4101_P1
Study First Received: September 18, 2010
Last Updated: August 15, 2013

Keywords provided by Seoul National University Hospital:
Allogenetic NK cells
Solid tumors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on August 16, 2017