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

August 15, 2013 updated by: Seoul National University Hospital

A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the overall response rate
Time Frame: 4-5 weeks
RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma
4-5 weeks
To evaluate the safety
Time Frame: 4 -5 weeks
NCI-CTCAE v3.0
4 -5 weeks
To evaluate the pharmacokinetics of allogeneic NK cells
Time Frame: 4-5 weeks
To quantify the persistence of donor NK cells in recipients
4-5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

GC Biopharma Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 18, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG4101_P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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