NSCLC Stage IIIBPhase 1NCT03515252
Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
A Phase 1 study testing Immune Killer Cells (IKC) in people with NSCLC Stage IIIB and NSCLC Stage IV, run by Ivy Life Sciences, Co., Ltd.
Trial summary
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- NSCLC Stage IIIB, NSCLC Stage IV, Hepatocellular Carcinoma by BCLC Stage
- What is being tested?
- Immune Killer Cells (IKC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2005to 7 Jun 2007
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects had voluntarily given written informed consent
- subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
- subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
- subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
- subjects' ECOG performance status ≤ 2
- subjects with life expectancy ≥ 3 months
Who cannot join
- subjects with medical history of gout
- subjects who had participated other clinical trials within 4 weeks before the screening visit
- subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
- subjects with clinically significant diseases other than cancer
- subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
- female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
- subjects with history of alcohol, drug or other substance abuse
- subjects with disease of bacteremia
About this study
Official title: A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
Read the detailed description
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IV, Hepatocellular Carcinoma by BCLC Stage, Lung Cancer, Liver Cancer
- Being tested
- Immune Killer Cells (IKC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Killer Cells (IKC)Biological
| Study group | Role | What they receive |
|---|---|---|
| Late stage lung cancer and liver cancer | Experimental | Immune Killer Cells (IKC) Receives: Biological: Immune Killer Cells (IKC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety]
Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
Measured: 5 months
Secondary outcomes (2)
Response Evaluation Criteria in Solid Tumors (RECIST)
Record net changes of tumor sizes
Measured: 4 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. Environmental) 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: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start26 Apr 2005
- Primary completion2 Nov 2006
- Study completion7 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIBStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivy Life Sciences, Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kuo-Ching Yang, MD, PhD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515252
- Sponsor's protocol ID
- IVY 01
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
- ClinicalTrials.gov ID
- NCT03515252
- Acronym / sponsor ID
- IVY 01
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IV, Hepatocellular Carcinoma by BCLC Stage, Lung Cancer, Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ivy Life Sciences, Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2005 (actual)
- Primary completion
- 2 Nov 2006 (actual)
- Study completion
- 7 Jun 2007 (actual)
- First posted
- 3 May 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.
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
Detailed description
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late stage lung cancer and liver cancer | Experimental | Biological: Immune Killer Cells (IKC)Immune Killer Cells (IKC) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects had voluntarily given written informed consent
- subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
- subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
- subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
- subjects' ECOG performance status ≤ 2
Key exclusion criteria (8 listed)
- subjects with medical history of gout
- subjects who had participated other clinical trials within 4 weeks before the screening visit
- subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
- subjects with clinically significant diseases other than cancer
- subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
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) | Biological | Late stage lung cancer and liver cancer |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 5 months
Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
2 secondary outcomes
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 4 months
Quality of Life (QOL)
Time frame: 5 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 9 May 2018.
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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.
Kuo-Ching Yang, MD, PhD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immune Killer Cells (IKC) in people with NSCLC Stage IIIB and NSCLC Stage IV, run by Ivy Life Sciences, Co., Ltd.
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 6 inclusion and 8 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2018.