A Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy (IVY03)

A Phase II Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy

In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments.

Possible adverse reaction can include slight fever and headache.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC) Stage IV
• Intervention / Treatment: Biological: Immune Killer Cells (IKC)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan
    • Tri Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age≧20 years old
2. Life expectancy≧3 months
3. Eastern Cooperative Oncology group (ECOG) score 0~2
4. Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...

Exclusion Criteria:

1. Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period
2. Patients with HIV, HTLV or active tuberculosis
3. Women who are pregnant or breast-feeding
4. Patients with drug or other substance abuse
5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)

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: Study Group; 26 patients who has successfully undergone the screening criteria will be enrolled for treatment. Immune Killer Cells (IKC) will be administered through Intravenous Injection (I.V.) Frequency: One injection per week, twenty-four injections on-treatment	Biological: Immune Killer Cells (IKC); Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety]	Adverse Events (AE) and Serious Adverse Events (SAE) according to National Cancer Institute Criteria for Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) will be recorded and evaluated for their relationship to the treatment	7 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. Enviromental) 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).	8 months

Collaborators and Investigators

• Sponsor: Ivy Life Sciences, Co., Ltd
• Collaborators: Taipei Veterans General Hospital, Taiwan; Tri-Service General Hospital
• Investigators: Principal Investigator: Yuh-Min Chen, MD, PhD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): February 16, 2020
• Study Completion (Actual): February 16, 2020

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: IKC; Immune Cell Therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IVY03

Drug and device information, study documents

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