Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT03656705
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2018-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events evaluated with CTCAE,version 4.0', 'timeFrame': '3 months', 'description': 'Safety evaluation'}, {'measure': 'Objective Response Rate', 'timeFrame': 'up to one year', 'description': 'Non-small cell lung carcinoma to CCCR-NK92 cell infusions'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate', 'timeFrame': 'up to one year'}, {'measure': 'Progression-free Survival', 'timeFrame': 'up to one year'}, {'measure': 'Overall Survival', 'timeFrame': 'up to one year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled.\n* 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks.\n* 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.\n\nExclusion Criteria:\n\n* 1.Pregnancy or breastfeeding.\n* 2.Known HIV, HBV or HCV infection.\n* 3.Active antoimmune disease.\n* 4.History of severe immediate hypersensitivity to any of the biological products including penicillin.\n* 5.Severe psychiatric disorder which might interfere with the study treatment or examination.\n* 6.Chronic heart failure NYHA≧III.\n* 7.Simultaneous participation in another clinical trial within 4 weeks.'}, 'identificationModule': {'nctId': 'NCT03656705', 'briefTitle': 'CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Xinxiang medical university'}, 'officialTitle': 'Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma', 'orgStudyIdInfo': {'id': 'CNK-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCCR-NK92 cells immunotherapy', 'description': 'Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.', 'interventionNames': ['Biological: CCCR-NK92 cells']}], 'interventions': [{'name': 'CCCR-NK92 cells', 'type': 'BIOLOGICAL', 'description': 'CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.', 'armGroupLabels': ['CCCR-NK92 cells immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '453000', 'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'The first Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinxiang medical university', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}