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

This study has been completed.

Sponsor:

Collaborator:

Green Cross Corp

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01212341

First received: September 18, 2010

Last updated: August 15, 2013

Last verified: August 2013

History of Changes

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 Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Cancer 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma
To evaluate the safety [ Time Frame: 4 -5 weeks ] [ Designated as safety issue: Yes ]
NCI-CTCAE v3.0
To evaluate the pharmacokinetics of allogeneic NK cells [ Time Frame: 4-5 weeks ] [ Designated as safety issue: No ]
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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212341

Locations


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

Sponsors and Collaborators

Seoul National University Hospital

Green Cross Corp

More Information

No publications provided


Responsible Party:	Tae Min Kim/Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01212341 History of Changes
Other Study ID Numbers:	MG4101_P1
Study First Received:	September 18, 2010
Last Updated:	August 15, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:


Allogenetic NK cells Lymphomas Solid tumors

Additional relevant MeSH terms:


Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases	Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 01, 2015

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