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
NCT ID: NCT03499834
Last Updated: 2020-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2017-12-05
2020-02-16
Brief Summary
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Possible adverse reaction can include slight fever and headache.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Immune Killer Cells (IKC)
Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment
Interventions
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Immune Killer Cells (IKC)
Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment
Eligibility Criteria
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Inclusion Criteria
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
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)
20 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Tri-Service General Hospital
OTHER
Ivy Life Sciences, Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yuh-Min Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Tri Service General Hospital
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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IVY03
Identifier Type: -
Identifier Source: org_study_id
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