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

Ivy Life Sciences

Status and phase: Completed; Phase 1

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

Treatments: Biological: Immune Killer Cells (IKC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03515252

IVY 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Late stage lung cancer and liver cancer

Experimental group

Description:

Immune Killer Cells (IKC)

Treatment:

Biological: Immune Killer Cells (IKC)