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Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor (MG4101)
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborator:
Green Cross Corporation
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
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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: 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:
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| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212341
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 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 |
| Study First Received: | September 18, 2010 |
| Last Updated: | August 15, 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 |
ClinicalTrials.gov processed this record on August 16, 2017