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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer (NSCLC) Stage IV

Intervention / Treatment
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* Biological: Immune Killer Cells (IKC)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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)<br>* Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 months | 
| 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). | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Cell Therapy, IKC