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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Liver Cancer; NSCLC Stage IV; Hepatocellular Carcinoma by BCLC Stage; NSCLC Stage IIIB
• Intervention / Treatment: Biological: Immune Killer Cells (IKC)

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Late stage lung cancer and liver cancer; Immune Killer Cells (IKC)	Biological: Immune Killer Cells (IKC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Evaluation Criteria in Solid Tumors (RECIST)	Record net changes of tumor sizes	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).	5 months

Collaborators and Investigators

• Sponsor: Ivy Life Sciences, Co., Ltd
• Investigators: Principal Investigator: Kuo-Ching Yang, MD, PhD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2005
• Primary Completion (Actual): November 2, 2006
• Study Completion (Actual): June 7, 2007

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Liver Neoplasms; Lung Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: IVY 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No