Non-small Cell Lung Cancer (NSCLC) Stage IVPhase 2IVY03NCT03499834
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
A Phase 2 study testing Immune Killer Cells (IKC) in people with Non-small Cell Lung Cancer (NSCLC) Stage IV, run by Ivy Life Sciences, Co., Ltd at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC) Stage IV
- What is being tested?
- Immune Killer Cells (IKC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 Dec 2017to 16 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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...
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Veterans General Hospital
Taipei
Tri Service General Hospital
Taipei
About this study
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
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.
- Being tested
- Immune Killer Cells (IKC)
- Keywords
- Immune Cell Therapy, IKC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Killer Cells (IKC)Biological
Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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 Receives: Biological: Immune Killer Cells (IKC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start5 Dec 2017
- Primary completion16 Feb 2020
- Study completion16 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC) Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivy Life Sciences, Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Yuh-Min Chen, MD, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499834
- Sponsor's protocol ID
- IVY03
- Acronym
- IVY03
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tseng YH, Ho CL, Chian CF, Chiang CL, Chao HS, Tsai CL, Perng WC, Hsiao CF, Chuang MH, Ko KH, Cheng YC, Chen SJ, Wang CJ, Chen YM. Immune killer cells treatment for previously treated stage IV NSCLC patients. Sci Rep. 2024 Aug 21;14(1):19374. doi: 10.1038/s41598-024-69587-x.
PubMed 39169058
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03499834
- Acronym / sponsor ID
- IVY03 / IVY03
- Keywords
- Immune Cell Therapy, IKC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ivy Life Sciences, Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH)
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 16 Feb 2020 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Immune Killer Cells (IKC)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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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...
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Killer Cells (IKC)Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment | Biological | Study Group |
Primary outcome
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
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 7 months
Quality of Life (QOL)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Derived from this study: PubMed 39169058Tseng YH, Ho CL, Chian CF, Chiang CL, Chao HS, Tsai CL, Perng WC, Hsiao CF, Chuang MH, Ko KH, Cheng YC, Chen SJ, Wang CJ, Chen YM. Immune killer cells treatment for previously treated stage IV NSCLC patients. Sci Rep. 2024 Aug 21;14(1):19374. doi: 10.1038/s41598-024-69587-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuh-Min Chen, MD, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Killer Cells (IKC) in people with Non-small Cell Lung Cancer (NSCLC) Stage IV, run by Ivy Life Sciences, Co., Ltd at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.