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

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ClinicalTrials.gov Identifier: NCT01212341
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : August 19, 2013
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by:
Seoul National University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Lymphomas Solid Tumors Biological: Allogeneic NK cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


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

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

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


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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212341


Locations
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Tae Min Kim/Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01212341     History of Changes
Other Study ID Numbers: MG4101_P1
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases