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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
NSCLC Stage IIIB NSCLC Stage IV Hepatocellular Carcinoma by BCLC Stage Lung Cancer Liver Cancer Biological: Immune Killer Cells (IKC) Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 26, 2005
Actual Primary Completion Date : November 2, 2006
Actual Study Completion Date : June 7, 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Late stage lung cancer and liver cancer
Immune Killer Cells (IKC)
 Biological: Immune Killer Cells (IKC)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 months ]
    Record net changes of tumor sizes

  2. 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).



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03515252


Sponsors and Collaborators
Ivy Life Sciences, Co., Ltd
Investigators
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Principal Investigator: Kuo-Ching Yang, MD, PhD Shin Kong Wu Ho-Su Memorial Hospital
More Information
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Responsible Party: Ivy Life Sciences, Co., Ltd
ClinicalTrials.gov Identifier: NCT03515252    
Other Study ID Numbers: IVY 01
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases