Back to resultsA 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)
Primary Purpose
Non-small Cell Lung Cancer (NSCLC) Stage IV
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Immune Killer Cells (IKC)
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) Stage IV focused on measuring Immune Cell Therapy, IKC
Eligibility Criteria
Inclusion Criteria:
- Age≧20 years old
- Life expectancy≧3 months
- Eastern Cooperative Oncology group (ECOG) score 0~2
- Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
- Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...
Exclusion Criteria:
- 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
- Patients with HIV, HTLV or active tuberculosis
- Women who are pregnant or breast-feeding
- Patients with drug or other substance abuse
- Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)
Sites / Locations
- Taipei Veterans General Hospital
- Tri Service General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
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
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
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
Incidence of Treatment-Emergent Adverse Events [Safety]
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
Quality of Life (QOL)
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).
Full Information
NCT ID
NCT03499834
First Posted
April 2, 2018
Last Updated
April 14, 2020
Sponsor
Ivy Life Sciences, Co., Ltd
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03499834
Brief Title
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
Acronym
IVY03
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
February 16, 2020 (Actual)
Study Completion Date
February 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivy Life Sciences, Co., Ltd
Collaborators
Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC) Stage IV
Keywords
Immune Cell Therapy, IKC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Immune Killer Cells (IKC)
Intervention Description
Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
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
Time Frame
7 months
Title
Quality of Life (QOL)
Description
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).
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≧20 years old
Life expectancy≧3 months
Eastern Cooperative Oncology group (ECOG) score 0~2
Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...
Exclusion Criteria:
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
Patients with HIV, HTLV or active tuberculosis
Women who are pregnant or breast-feeding
Patients with drug or other substance abuse
Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuh-Min Chen, MD, PhD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
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
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