Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 10:29 AM
Study NCT ID:
NCT06927466
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Approximately 2 years', 'description': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'The overall response rate (ORR)', 'timeFrame': '3 months', 'description': 'Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 2 years', 'description': 'Determination of the overall survival times of all patients.'}, {'measure': 'PK(Pharmacokinetics):Tmax', 'timeFrame': 'Approximately 2 years', 'description': 'Time to peak plasma concentration (Tmax)'}, {'measure': 'PK(Pharmacokinetics):Cmax', 'timeFrame': 'Approximately 2 years', 'description': 'Maximum serum concentration(Cmax)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；\n2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；\n3. Documentation of CD19/CD22 tumor expression\n\n3\\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \\>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.\n\n\\-\n\nExclusion Criteria:\n\n1. Active CNS involvement by malignancy；\n2. Isolated extramedullary leukemia recurrence；\n3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;\n4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.\n\n4\\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.\n\n7\\. Other situations deemed inappropriate for participation in this study by the investigator.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06927466', 'briefTitle': 'A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.'}, 'officialTitle': 'A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.', 'orgStudyIdInfo': {'id': 'B019-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B019', 'interventionNames': ['Biological: B019']}], 'interventions': [{'name': 'B019', 'type': 'BIOLOGICAL', 'description': 'B019： Intravenous infusion, 1.0×10\\^6 CAR T cell/kg-10.0×10\\^6 CAR T cell/kg', 'armGroupLabels': ['B019']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yifei Cheng', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei He', 'role': 'CONTACT'}], 'facility': 'Jiangxi Province pediatric hospital', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Li', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingbo Shao', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Chen', 'role': 'CONTACT'}], 'facility': "Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Suzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaoyan Hu', 'role': 'CONTACT'}], 'facility': "Children's Hospital of Soochow University", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Kui', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyu Li', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Jing Chen', 'role': 'CONTACT', 'email': 'chenjing@scmc.com.cn', 'phone': '0086-021-38626161'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}