Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT03671460
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-center, open-label, nonrandomized, no control, prospective clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of adverse events', 'timeFrame': '6 months', 'description': 'Percentage of participants with adverse events'}], 'secondaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': '6 months', 'description': 'The percentage of participants who achieved complete remission (CR) over all participants (CRR).'}, {'measure': 'objective remission rate', 'timeFrame': '6 months', 'description': 'The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['B-cell acute lymphoblastic leukemia', 'CD19 CAR-T'], 'conditions': ['B-cell Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).', 'detailedDescription': 'In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. More than 1 year;\n2. CD19 positive B-cell acute lymphoblastic leukemia;\n3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.\n4. Expected to survive for more than 3 months;\n5. Informed consent is signed by a subject or his lineal relation.\n\nExclusion Criteria:\n\n1. Recent or current use of glucocorticoid or other immunosuppressor;\n2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;\n3. Has a graft-versus-host response and requires the use of immunosuppressants；\n4. Drug uncontrollable central nervous system leukemia；\n5. Pregnant or lactating female；\n6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year；\n7. A history of other malignant tumors;\n8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study."}, 'identificationModule': {'nctId': 'NCT03671460', 'briefTitle': 'CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tianjin Mycure Medical Technology Co., Ltd'}, 'officialTitle': 'Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)', 'orgStudyIdInfo': {'id': 'TianjinMycure-LDP-CD19 CAR-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD19-CAR-T Cells', 'description': 'Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.', 'interventionNames': ['Biological: CD19 CAR-T cells']}], 'interventions': [{'name': 'CD19 CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.', 'armGroupLabels': ['CD19-CAR-T Cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '065000', 'city': 'Langfang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peihua Lu, MD, PhD', 'role': 'CONTACT', 'email': 'peihua_lu@126.com', 'phone': '18611636172'}], 'facility': 'Hebei Yanda Ludaopei Hospital', 'geoPoint': {'lat': 39.52079, 'lon': 116.71471}}], 'centralContacts': [{'name': 'Chaoting Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangchaoting1@163.com', 'phone': '86-010-88196768'}], 'overallOfficials': [{'name': 'Peihua Lu, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Yanda Ludaopei Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "We don't decide when to share IPD and what will be shared."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Mycure Medical Technology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}