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

NCT ID: NCT03515252

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-26
• Study Completion Date: 2007-06-07

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.

Conditions

NSCLC Stage IIIB; NSCLC Stage IV; Hepatocellular Carcinoma by BCLC Stage; Lung Cancer; Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Late stage lung cancer and liver cancer

Immune Killer Cells (IKC)

Group Type: EXPERIMENTAL

Immune Killer Cells (IKC)

Intervention Type: BIOLOGICAL

Interventions

Immune Killer Cells (IKC)

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivy Life Sciences, Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuo-Ching Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Other Identifiers

IVY 01

Identifier Type: -

Identifier Source: org_study_id