Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT04747093
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2021-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induced-T Cell Like NK Cells for B Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3 months', 'description': "Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis."}, {'measure': 'ORR', 'timeFrame': '6 months', 'description': "Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis."}, {'measure': 'ORR', 'timeFrame': '12 months', 'description': "Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis."}, {'measure': 'OS', 'timeFrame': '1 year', 'description': 'overall survival'}, {'measure': 'DFS', 'timeFrame': '1 year', 'description': 'disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITNK Cells', 'CAR', 'B Cell Malignancy'], 'conditions': ['B Cell Leukemia', 'B Cell Lymphoma', 'B-cell Acute Lymphoblastic Leukemia', 'B-cell Lymphoma Recurrent', 'B-cell Lymphoma Refractory']}, 'descriptionModule': {'briefSummary': 'Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with CD19 positive B-cell acute leukemia\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<2\n* ALT/ AST \\<3 x normal\n* Bilirubin \\< 2.0 mg/dl\n* Creatinine \\< 2.5 mg/dl and less than 2.5x normal for age\n* LVEF\\< 45%\n* Accept white blood cell collection\n* Provide informed consent\n\nExclusion Criteria:\n\n* Previous treatment with investigational gene or cell therapy medicine products\n* Active hepatitis B , hepatitis C or HIV infection\n* Uncontrolled active infection\n* Presence of grade 2-4 acute or extensive chronic GVHD\n* Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,\n* Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.\n* Any uncontrolled active medical disorder that would preclude participation as outlined.\n* Received non-diagnostic purposes major surgery within the past 4 weeks\n* Participated in any other clinical study within the past 4 weeks\n* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.\n* Pregnancy or breast-feeding women\n* Use of prohibited drugs:\n* Steroids: Therapeutic doses of steroids must be stopped \\> 72 hours prior to ITNK Cells infusion\n* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \\> 4 weeks prior to ITNK Cells infusion\n* GVHD therapies: Any drug used for GVHD must be stopped \\> 4 weeks prior to ITNK Cells infusion\n* Any situation that may increase the risk of the test or interfere with the test results"}, 'identificationModule': {'nctId': 'NCT04747093', 'briefTitle': 'Induced-T Cell Like NK Cells for B Cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Induced-T Cell Like NK Cellular Immunotherapy for Refractory B Cell Malignancies', 'orgStudyIdInfo': {'id': 'ITNK-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ITNK group', 'interventionNames': ['Biological: CAR-ITNK cells']}], 'interventions': [{'name': 'CAR-ITNK cells', 'type': 'BIOLOGICAL', 'description': 'CAR-ITNK cells will be infused over 10-15 minutes on Day 0.', 'armGroupLabels': ['ITNK group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ren Lin, MD', 'role': 'CONTACT', 'email': 'lansinglinren@hotmail.com', 'phone': '+86-020-61641613'}, {'name': 'Qifa Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ren Lin, MD', 'role': 'CONTACT', 'email': 'lansinglinren@hotmail.com', 'phone': '+86-020-62787883'}], 'overallOfficials': [{'name': 'Qi-fa Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}