Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-06 @ 9:21 PM
Study NCT ID:
NCT03193567
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of High Efficient Killing Cell Therapy for Advanced NSCLC
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': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-18', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '2 years', 'description': 'Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.'}, {'measure': 'Imaging evaluation before and after treatment', 'timeFrame': '0 day and 60 day', 'description': 'the SUV index of PET-CT before cell injection and after the whole course of the treatment'}], 'primaryOutcomes': [{'measure': 'safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment', 'timeFrame': '2 years', 'description': 'Occurrence of study related adverse events as assessed by CTCAE v4.0'}], 'secondaryOutcomes': [{'measure': 'efficacy: complete response; partial response; stable disease; progression disease; progression free survival.', 'timeFrame': '2 years', 'description': 'The efficacy of the treatment is assessed according to (RECIST1.1)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer', 'detailedDescription': 'Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients' age from 18 years to 70 years.\n* Patients who have a life expectancy of at least 3 months.\n* pathologically confirmed non-small cell lung cancer.\n* failed in previous standard chemotherapy and targeted therapy.\n* Karnofsky performance status 0-1.\n* adequate organ functions.\n\nExclusion Criteria:\n\n* Pregnant and lactating women.\n* Patients with T cell lymphoma, syphilis, AIDS or combination\n* Patients with highly allergic or have a history of severe allergies\n* Patients with severe hepatic or renal dysfunction\n* Patients with severe autoimmune disease or who is being treated with immunosuppressive agents\n* Patients with severe infection not controlled or High fever\n* Patients with organ transplantation or waiting for organ transplantation.\n* Patients with brain metastasis\n* Patients with severe coagulopathy (e.g. hemophilia)\n* Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily."}, 'identificationModule': {'nctId': 'NCT03193567', 'acronym': 'HEART', 'briefTitle': 'Study of High Efficient Killing Cell Therapy for Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'RTS-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEKT cell', 'description': 'Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.', 'interventionNames': ['Biological: HEKT cell']}], 'interventions': [{'name': 'HEKT cell', 'type': 'BIOLOGICAL', 'otherNames': ['High Efficient Killing Cell Therapy'], 'description': '3 cycles of HEKT cell treatment', 'armGroupLabels': ['HEKT cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei hai Du, Master', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lei H Du, M.S', 'role': 'CONTACT', 'email': 'sealing821201@hotmail.com', 'phone': '13918570392'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Houchao Biotechnology Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hecheng Li M.D., Ph.D', 'investigatorAffiliation': 'Ruijin Hospital'}}}}