Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT03614858
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2018-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2018-07-28', 'studyFirstSubmitQcDate': '2018-07-28', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': '12 months', 'description': 'Adverse events are evaluated with CTCAE V4.03'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19', 'CD22'], 'conditions': ['Leukemia, B-cell']}, 'descriptionModule': {'briefSummary': 'This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.', 'detailedDescription': 'The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \\<2 year). The study will enroll 20 evaluable patients as follows:\n* Age 6-65 years.\n* Left ventricular ejection fractions≥ 0.5 by echocardiography.\n* Creatinine \\< 1.6 mg/dL.\n* Aspartate aminotransferase/aspartate aminotransferase \\< 3x upper limit of normal.\n* Bilirubin \\<2.0 mg/dL.\n* Karnofsky performance status ≥ 60\n* Expected survival time ≥ 3 months (according to investigator's judgement)\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Uncontrolled active infection.\n* Active hepatitis B or hepatitis C infection.\n* Class III/IV cardiovascular disability according to the New York Heart Association Classification.\n* HIV infection.\n* Patients with history of seizure\n* Active central nervous system leukemia"}, 'identificationModule': {'nctId': 'NCT03614858', 'briefTitle': 'CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd'}, 'officialTitle': 'Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.', 'orgStudyIdInfo': {'id': 'UnicarTherapy201807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.', 'interventionNames': ['Biological: CART-19/22']}], 'interventions': [{'name': 'CART-19/22', 'type': 'BIOLOGICAL', 'description': 'Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10\\^6 CART-19/22 cells/kg).', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaowen Tang, Ph.D', 'role': 'CONTACT', 'email': 'tangxiaowen@suda.edu.cn', 'phone': '(0086)51267781856'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Xiaowen Tang, Ph.D.', 'role': 'CONTACT', 'email': 'tangxiaowen@suda.edu.cn', 'phone': '(0086)51267781856'}, {'name': 'Lei Yu, Ph.D.', 'role': 'CONTACT', 'email': 'ylyh188@163.com', 'phone': '8613818629089'}], 'overallOfficials': [{'name': 'Xiaowen Tang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, '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'}}}}