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A Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy (IVY03)

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.
 
ClinicalTrials.gov Identifier: NCT03499834
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Information provided by (Responsible Party):
Ivy Life Sciences, Co., Ltd

Brief Summary:

In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments.

Possible adverse reaction can include slight fever and headache.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Stage IV Biological: Immune Killer Cells (IKC) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
Actual Study Start Date : December 5, 2017
Actual Primary Completion Date : February 16, 2020
Actual Study Completion Date : February 16, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
26 patients who has successfully undergone the screening criteria will be enrolled for treatment. Immune Killer Cells (IKC) will be administered through Intravenous Injection (I.V.) Frequency: One injection per week, twenty-four injections on-treatment
Biological: Immune Killer Cells (IKC)
Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 6 months ]
    The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 7 months ]
    Adverse Events (AE) and Serious Adverse Events (SAE) according to National Cancer Institute Criteria for Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) will be recorded and evaluated for their relationship to the treatment

  2. Quality of Life (QOL) [ Time Frame: 8 months ]

    The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL)

    This questionnaire produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain (1. Physical health 2. Psychological 3. Social relationships 4. Enviromental) Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).

    The mean score of items within each domain is used to calculate the domain score (min: 0 max: 100)

    Domain scores are then calculated (divide domain score by 4) to produce a final QOL Score (i.e. higher scores denote higher quality of life min: 0 max:100).




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
Criteria

Inclusion Criteria:

  1. Age≧20 years old
  2. Life expectancy≧3 months
  3. Eastern Cooperative Oncology group (ECOG) score 0~2
  4. Cytologically-or histologically-confirmed non-small cell lung cancer(NSCLC)
  5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...

Exclusion Criteria:

  1. Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period
  2. Patients with HIV, HTLV or active tuberculosis
  3. Women who are pregnant or breast-feeding
  4. Patients with drug or other substance abuse
  5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)

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): NCT03499834


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Ivy Life Sciences, Co., Ltd
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Investigators
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Principal Investigator: Yuh-Min Chen, MD, PhD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Ivy Life Sciences, Co., Ltd
ClinicalTrials.gov Identifier: NCT03499834    
Other Study ID Numbers: IVY03
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020

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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 Ivy Life Sciences, Co., Ltd:
Immune Cell Therapy
IKC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms