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

NCT03515252 | Completed Phase 1 DMC

• 1 other identifier: IVY 01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Response Evaluation Criteria in Solid Tumors (RECIST)

  4 months

• Quality of Life (QOL)

  5 months

Study Arms (1)

Late stage lung cancer and liver cancer

EXPERIMENTAL

Immune Killer Cells (IKC)

Biological: Immune Killer Cells (IKC)

Interventions

Immune Killer Cells (IKC) BIOLOGICAL

Late stage lung cancer and liver cancer

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivy Life Sciences, Co., Ltd: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Kuo-Ching Yang, MD, PhD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 3, 2018
• Study Start: April 26, 2005
• Primary Completion: November 2, 2006
• Study Completion: June 7, 2007
• Last Updated: May 9, 2018

Record last verified: 2018-04