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

Primary Purpose

NSCLC Stage IIIB, NSCLC Stage IV, Hepatocellular Carcinoma by BCLC Stage

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Immune Killer Cells (IKC)
Sponsored by
Ivy Life Sciences, Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC Stage IIIB

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Late stage lung cancer and liver cancer

    Arm Description

    Immune Killer Cells (IKC)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Response Evaluation Criteria in Solid Tumors (RECIST)
    Record net changes of tumor sizes
    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).

    Full Information

    First Posted
    April 23, 2018
    Last Updated
    May 3, 2018
    Sponsor
    Ivy Life Sciences, Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03515252
    Brief Title
    Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 26, 2005 (Actual)
    Primary Completion Date
    November 2, 2006 (Actual)
    Study Completion Date
    June 7, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ivy Life Sciences, Co., Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NSCLC Stage IIIB, NSCLC Stage IV, Hepatocellular Carcinoma by BCLC Stage, Lung Cancer, Liver Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Late stage lung cancer and liver cancer
    Arm Type
    Experimental
    Arm Description
    Immune Killer Cells (IKC)
    Intervention Type
    Biological
    Intervention Name(s)
    Immune Killer Cells (IKC)
    Primary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety]
    Description
    Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Response Evaluation Criteria in Solid Tumors (RECIST)
    Description
    Record net changes of tumor sizes
    Time Frame
    4 months
    Title
    Quality of Life (QOL)
    Description
    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).
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kuo-Ching Yang, MD, PhD
    Organizational Affiliation
    Shin Kong Wu Ho-Su Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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