Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT03499834
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety]', 'timeFrame': '7 months', 'description': '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'}, {'measure': 'Quality of Life (QOL)', 'timeFrame': '8 months', 'description': "The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL)\n\nThis 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).\n\nThe mean score of items within each domain is used to calculate the domain score (min: 0 max: 100)\n\nDomain 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)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune Cell Therapy', 'IKC'], 'conditions': ['Non-small Cell Lung Cancer (NSCLC) Stage IV']}, 'referencesModule': {'references': [{'pmid': '39169058', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPossible adverse reaction can include slight fever and headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age≧20 years old\n2. Life expectancy≧3 months\n3. Eastern Cooperative Oncology group (ECOG) score 0\\~2\n4. Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)\n5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...\n\nExclusion Criteria:\n\n1. 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\n2. Patients with HIV, HTLV or active tuberculosis\n3. Women who are pregnant or breast-feeding\n4. Patients with drug or other substance abuse\n5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)"}, 'identificationModule': {'nctId': 'NCT03499834', 'acronym': 'IVY03', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivy Life Sciences, Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IVY03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study 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', 'interventionNames': ['Biological: Immune Killer Cells (IKC)']}], 'interventions': [{'name': 'Immune Killer Cells (IKC)', 'type': 'BIOLOGICAL', 'description': 'Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yuh-Min Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivy Life Sciences, Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}