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)
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|ClinicalTrials.gov Identifier: NCT03499834|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : May 20, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||December 5, 2019|
|Estimated Study Completion Date :||June 5, 2020|
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
- 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
- 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
- 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).
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
|Taipei Veterans General Hospital|
|Tri Service General Hospital|
|Principal Investigator:||Yuh-Min Chen, MD, PhD||Taipei Veterans General Hospital, Taiwan|