Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-15 @ 7:12 PM
Study NCT ID:
NCT02794961
Status:
UNKNOWN
Last Update Posted:
2016-06-09
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'timeFrame': '12 months', 'description': 'The B cells in peripheral blood of all enrolled patients will be monitored every week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent or Refractory B Cell Malignancy']}, 'referencesModule': {'references': [{'pmid': '23243285', 'type': 'RESULT', 'citation': 'Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.', 'detailedDescription': 'CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than four years of age\n* Survival time\\>12 weeks\n* B cell hematological malignancies by pathological examination\n* Chemotherapy failure or recurrent B cell malignancy\n* Creatinine\\< 2.5mg/dl\n* Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\\< 3 fold of normal level\n* Bilirubin\\<2.0mg/dl\n* Karnofsky Performance Status\\>50% at the time of screening\n* Adequate pulmonary, renal, hepatic, and cardiac function\n* Fail in autologous or allogenic haemopoietic stem cell transplantation\n* Free of leukocytes removal contraindications\n* Voluntarily join CAR-T clinical trial\n* Understand and sign written informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening\n* Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.\n* Abnormal vital signs\n* Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2\n* General infection or local severe infection, or other infection that is not controlled\n* Dysfunction in lung, heart, kidney and brain\n* Severe autoimmune diseases\n* Other symptoms that are not applicable for CAR-T'}, 'identificationModule': {'nctId': 'NCT02794961', 'briefTitle': 'CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Xuzhou Medical University'}, 'officialTitle': 'Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies', 'orgStudyIdInfo': {'id': 'AF-08/04.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD22 CAR-T', 'description': 'Enrolled patients will receive three escalating doses of autologous CAR-T.', 'interventionNames': ['Biological: CD22 CAR-T']}], 'interventions': [{'name': 'CD22 CAR-T', 'type': 'BIOLOGICAL', 'description': 'Autologous CAR-T cells with average 1\\*10\\^6 cells/kg body weight', 'armGroupLabels': ['CD22 CAR-T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Cao, M.D., Ph.D.', 'role': 'CONTACT'}], 'facility': 'Affiliated hospital of Xuzhou medical college', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Jiang Cao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'zimu05067@163.com', 'phone': '8651685802291'}, {'name': 'JunNian Zheng, M.D., Ph.D.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'KaiLin Xu, MD. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kai Lin Xu; Jun Nian Zheng', 'class': 'OTHER'}, 'collaborators': [{'name': 'iCarTAB BioMed Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Kai Lin Xu; Jun Nian Zheng', 'investigatorAffiliation': 'Xuzhou Medical University'}}}}