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Haploidentical NK Cells After Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (Medi-NK)

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. Identifier: NCT03366064
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : July 8, 2019
Korea Research Institute of Bioscience & Biotechnology
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center

Brief Summary:
This phase 1 trial investigate safety and maximum tolerated dose of natural killer (NK) cells derived from haploidentical family donors in patients with non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: Pemetrexed and donor-derived NK cell infusion Phase 1

Detailed Description:

Eligible patients receive pemetrexed 500 mg/m2 intravenously (Day 1). On Day 8, patients receive donor-derived NK cells via a central venous catheter.

The NK cell dose is as follows;

Level 1: 1.25 X 109 cells Level 2: 2.50 X 109 cells Level 3: 5.00 X 109 cells

Three patients each will be treated on each dose level.

Two weeks prior to donor NK cell administration to patients, HLA-haploidentical family member of the patients undergo leukapheresis after G-CSF injections to collect hematopoietic stem cells.

These donor cells are then taken to the laboratory, where they were differentiated into NK cells ex vivo over approximately over 2-week period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Haploidentical Natural Killer (NK) Cells in Combination With Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pemetrexed and donor NK cell infusion
Eligible patients with stage 4 non-small cell lung cancer receive NK cells derived from HLA-haploidentical family donors. One week prior to NK cell infusion, patients receive pemetrexed (500 mg/m2) intravenous infusion
Biological: Pemetrexed and donor-derived NK cell infusion
Patients are administered with donor-derived NK cells one week after pemetrexed infusion

Primary Outcome Measures :
  1. maximum tolerated dose of donor NK cells [ Time Frame: 6 weeks ]
    determine the dose of NK cells that can be given within dose-limiting toxicities

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically confirmed non-small cell lung cancer stage 4 (by AJCC 7th)
  • Age, 20 years of age or older
  • ECOG performance status, 0-2
  • Life expectancy ≥3 months
  • Patients should have at least one measurable lesion according to RECIST Criteria v1.1
  • Failure after primary systemic treatment with a regimen including platinum-containing agent (primary systemic treatment may be adjuvant chemotherapy or chemo-radiotherapy, given within 12 months)
  • Adequate bone marrow function (Hb ≥9 g/dL; ANC ≥1,500/uL; and platelet count ≥75,000/uL)
  • Adequate renal function (serum creatinine <1 x ULN or CLcr ≥45 mL/min by Cockroft and Gault formula
  • Adequate liver function (total bilirubin <1.5 x ULN; AST and ALT <3 x ULN; and ALP <3 x ULN, unless there is bone metastases without evidence of liver disease)
  • Patients should have a suitable HLA-haploidentical family member who is willing to donate hematopoietic stem cells
  • Patients should sign informed consent voluntarily

Exclusion Criteria:

  • Patients who received anti-cancer chemotherapeutic or biological agents within 3 weeks. Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTC AE ver 4.0 are not eligible as well.
  • Patients with contraindication for any medication planned to be administered in the study
  • Patients with significant fluid accumulation in third space (for example, pleural or pericardial effusion) that can not be controlled by drainage
  • Active infectious process
  • Inability to discontinue aspirin over 1.3 g daily or other NSAIDs. Patients cannot take aspirin or NSAIDs within 5 days of pemetrexed administration
  • Major surgery within 4 weeks of study participation
  • Palliative radiation therapy within 1 week of study participation
  • Acute myocardial infarction within 6 months of study participation. History of uncontrolled arrhythmia, symptomatic angina, or symptomatic heart failure
  • Past or current history of CNS metastasis (with exception of those patients who completed treatment of CNS metastasis and not received steroid treatment or whole brain radiotherapy within 2 weeks of screening visit or not received gamma knife treatment within 1 week of screening visit)
  • History of malignancy (other than skin basal cell carcinoma, carcinoma in situ of uterine cervix, or thyroid cancer) within 5 years
  • Pregnant or lactating women. Child-bearing women who are not willing to avoid pregnancy by contraceptives
  • Man not agreeing to contraceptive measures such as condom or abstinence (It is recommended that contraceptive measures be used until 6 months after pemetrexed treatment)
  • Other serious illness or medical condition

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 identifier (NCT number): NCT03366064

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Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology
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Principal Investigator: Kyoo-Hyung Lee, MD University of Ulsan, Asan Medical Center

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Responsible Party: Kyoo-Hyung Lee, Professor, Hematology, Asan Medical Center Identifier: NCT03366064    
Other Study ID Numbers: 2016-0607
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kyoo-Hyung Lee, Asan Medical Center:
Non-small cell lung cancer
Natural killer cells
HLA-haploidentical family donor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors