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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)

I

Ivy Life Sciences

Status and phase

Completed
Phase 2

Conditions

Non-small Cell Lung Cancer (NSCLC) Stage IV

Treatments

Biological: Immune Killer Cells (IKC)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Study Group
Experimental group
Description:
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
Treatment:
Biological: Immune Killer Cells (IKC)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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