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Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515252
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ivy Life Sciences, Co., Ltd

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE April 26, 2005
Actual Primary Completion Date November 2, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03515252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 months ]
    Record net changes of tumor sizes
  • Quality of Life (QOL) [ Time Frame: 5 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. 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
Official Title  ICMJE 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
Brief 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). 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC Stage IIIB
  • NSCLC Stage IV
  • Hepatocellular Carcinoma by BCLC Stage
  • Lung Cancer
  • Liver Cancer
Intervention  ICMJE Biological: Immune Killer Cells (IKC)
Study Arms  ICMJE Experimental: Late stage lung cancer and liver cancer
Immune Killer Cells (IKC)
Intervention: Biological: Immune Killer Cells (IKC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 7, 2007
Actual Primary Completion Date November 2, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. subjects had voluntarily given written informed consent
  2. subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
  3. subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
  4. 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
  5. subjects' ECOG performance status ≤ 2
  6. subjects with life expectancy ≥ 3 months

Exclusion Criteria:

  1. subjects with medical history of gout
  2. subjects who had participated other clinical trials within 4 weeks before the screening visit
  3. subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
  4. subjects with clinically significant diseases other than cancer
  5. subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
  6. female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
  7. subjects with history of alcohol, drug or other substance abuse
  8. subjects with disease of bacteremia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515252
Other Study ID Numbers  ICMJE IVY 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ivy Life Sciences, Co., Ltd
Study Sponsor  ICMJE Ivy Life Sciences, Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kuo-Ching Yang, MD, PhD Shin Kong Wu Ho-Su Memorial Hospital
PRS Account Ivy Life Sciences, Co., Ltd
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP