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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Lymphomas Solid Tumors | Biological: Allogeneic NK cells | Phase 1 |
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 |

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 |
- 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
- 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

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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

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