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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01212341

First Posted: September 30, 2010

Last Update Posted: August 19, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Green Cross Corporation

Information provided by:

Seoul National University Hospital

Purpose

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

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

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	September 18, 2010
First Posted:	September 30, 2010
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

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