Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-13 @ 11:04 PM
Study NCT ID:
NCT03064269
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2017-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2017-02-18', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The complete remission (CR) rate', 'timeFrame': 'Participants will be followed for the duration of the treatment, an expected average of 12 months', 'description': 'The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CNS B cell acute lymphocytic leukemia'], 'conditions': ['B-cell Acute Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '32745961', 'type': 'DERIVED', 'citation': 'Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.', 'detailedDescription': 'CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia\n2. ALT/ AST 《 3x normal\n3. Creatinine 《 3x normal\n4. Age:10-60.\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B , hepatitis C or HIV infection\n2. Uncontrolled active infection\n3. Pregnancy or breast-feeding women\n4. Survival less than four weeks'}, 'identificationModule': {'nctId': 'NCT03064269', 'briefTitle': 'CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd'}, 'officialTitle': 'CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'UnicarTherapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.', 'interventionNames': ['Biological: CD19 CAR-T cells']}], 'interventions': [{'name': 'CD19 CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng-Li Xue, Ph.D', 'role': 'CONTACT', 'email': 'slxue@suda.edu.cn', 'phone': '86-13328008851'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Sheng-Li Xue, MD', 'role': 'CONTACT', 'email': 'slxue@suda.edu.cn', 'phone': '86-13328008851'}, {'name': 'Lei Yu, Ph.D', 'role': 'CONTACT', 'email': 'ylyh188@163.com', 'phone': '86-13818629089'}], 'overallOfficials': [{'name': 'Sheng-Li Xue, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}