Clinical trial NCT03515252: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: NSCLC Stage IIIB
NSCLC Stage IV
Hepatocellular Carcinoma by BCLC Stage
Lung Cancer
Liver Cancer
Lead sponsor: Ivy Life Sciences, Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 5 months
Secondary outcomes:
measure: Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 4 months
measure: Quality of Life (QOL)
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Kuo-Ching Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: