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Completed

NCT Number: NCT03499834

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Stage IV Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taipei Veterans General Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Patients with HIV, HTLV or active tuberculosis
  • Women who are pregnant or breast-feeding
  • Patients with drug or other substance abuse
  • Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)

Treatment and study plan

Immune Killer Cells (IKC)

Biological

Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 6 months

    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

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: 7 months

    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

  2. Quality of Life (QOL)

    Time frame: 8 months

    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).

Sponsors and collaborators

Lead sponsor

Ivy Life Sciences, Co., Ltd

Industry

Collaborators

  • Taipei Veterans General Hospital, Taiwan
  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

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

Acronym: IVY03

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2018
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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