NCT03499834

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

April 2, 2018

Last Update Submit

April 14, 2020

Conditions

Non-small Cell Lung Cancer (NSCLC) Stage IV

Keywords

Immune Cell TherapyIKC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events [Safety]

    7 months

  • Quality of Life (QOL)

    8 months

Study Arms (1)

Study Group

EXPERIMENTAL

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)

Interventions

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

Study Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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...

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri Service General Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Tseng YH, Ho CL, Chian CF, Chiang CL, Chao HS, Tsai CL, Perng WC, Hsiao CF, Chuang MH, Ko KH, Cheng YC, Chen SJ, Wang CJ, Chen YM. Immune killer cells treatment for previously treated stage IV NSCLC patients. Sci Rep. 2024 Aug 21;14(1):19374. doi: 10.1038/s41598-024-69587-x.

    PMID: 39169058DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yuh-Min Chen, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 17, 2018

Study Start

December 5, 2017

Primary Completion

February 16, 2020

Study Completion

February 16, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Locations

TW(2)