Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 11:12 PM
Study NCT ID:
NCT03574168
Status:
UNKNOWN
Last Update Posted:
2018-06-29
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19-CAR-T Cells in Patients With R/R 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate, ORR', 'timeFrame': 'Up to Day90 after the CD19-CAR-T cell infusion', 'description': 'The percentage of participants who achieved complete remission (CR) over all participants (CRR).\n\nThe percentage of participants who achieved partial remission (PR) over all participants (PRR).'}], 'secondaryOutcomes': [{'measure': 'The amount of CAR-T cells remaining in vivo', 'timeFrame': '2 years after cell infusion.', 'description': 'Measure and analyze monthly'}, {'measure': 'The lifetime of CAR-T cells remaining in vivo', 'timeFrame': '2 years after cell infusion.', 'description': 'Measure and analyze monthly'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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 autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).', 'detailedDescription': "Primary objective:\n\nTo investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.\n\nSecondary objective:\n\nTo Assess the patient's quality of life after receiving the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient;\n2. Age 3-70 years old;\n3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;\n4. B cells are positive for CD19 expression;\n5. Peripheral blood tumor cell load \\<50%; 6. KPS score \\>50 points;\n\n7\\. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.\n\nExclusion Criteria:\n\n1. Patients with non-B cell acute leukemia;\n2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities\n3. Active infection;\n4. Human immunodeficiency virus (HIV) positive;\n5. Acute and chronic graft-versus-host disease (GVHD)\\> Level 1；\n6. Pregnant or lactating women;\n7. Patients do not agree to use effective contraception during the treatment period and following 3 months;\n8. Patients who participated in other clinical studies at the same time;\n9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;\n10. Long-term use greater doses of hormones than physiological doses."}, 'identificationModule': {'nctId': 'NCT03574168', 'briefTitle': 'CD19-CAR-T Cells in Patients With R/R B-ALL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioceltech Therapeutics, 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': 'BT-ALL-001-v2'}, 'secondaryIdInfos': [{'id': 'ChiCTR1800016541', 'type': 'REGISTRY', 'domain': 'Chinese Clinical Trial Registry'}]}, '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 or subjects' relatives which depends on their conditions, 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': 'Zhongwei Xu, MD, Phd', 'role': 'CONTACT', 'email': 'willyxu001@bioceltech.com', 'phone': '+86 010-69739722'}], 'overallOfficials': [{'name': 'Peihua Lu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Yanda Ludaopei Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioceltech Therapeutics, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}