Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-22 @ 1:38 PM
Study NCT ID:
NCT02259556
Status:
RECRUITING
Last Update Posted:
2016-01-28
First Post:
2014-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2014-10-05', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'in vivo existence of CART30', 'timeFrame': '1 year', 'description': 'Measure mainly by the changes of CAR molecule levels in blood'}], 'primaryOutcomes': [{'measure': 'Occurrence of related adverse events', 'timeFrame': 'untill week 24'}], 'secondaryOutcomes': [{'measure': 'Anti-tumor response to CART30 cell infusions', 'timeFrame': 'Up to 24 weeks', 'description': 'Evaluated mainly by computed tomography scanning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Hodgkin's Lymphoma", "Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).", 'detailedDescription': "When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.\n\nExtra blood will be drawn to measure the persistence of CART30 in vivo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.\n* Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.\n* Karnofsky or Lansky score greater than 60%.\n* Expected survival\\>12 weeks.\n* Creatinine\\<2.5mg/dl.\n* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\\<3 fold normal.\n* Bilirubin\\<2.5mg/dl.\n* Pulse oximetry of \\>90% on room air.\n* Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.\n* Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.\n* Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.\n\nExclusion Criteria:\n\n* Active infection such as hepatitis B or C.\n* Receive anti-CD30 antibody-based therapy within recent 6 weeks.\n* Current use of systemic corticosteroids.\n* Pregnant or lactating.\n* Confirmed tumor in pulmonary and archenteric tissues.'}, 'identificationModule': {'nctId': 'NCT02259556', 'acronym': 'CART30', 'briefTitle': 'CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-CD30 CAR T cells', 'description': 'Patients receive CART30 cell infusions with an escalation dose.', 'interventionNames': ['Biological: CART30']}], 'interventions': [{'name': 'CART30', 'type': 'BIOLOGICAL', 'otherNames': ['anti-CD30 CAR T cells'], 'description': 'Cells will be infused 1 day after the completion of conditioning regimen.', 'armGroupLabels': ['anti-CD30 CAR T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Han, Ph.D', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-10-66937463'}, {'name': 'Quanshun Wang, Ph.D', 'role': 'CONTACT', 'email': 'wqs63@sohu.com', 'phone': '86-10-66939486'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Weidong Han, Ph.D', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-10-66937463'}, {'name': 'Quanshun Wang, Ph.D', 'role': 'CONTACT', 'email': 'wqs63@sohu.com', 'phone': '86-10-66939486'}], 'overallOfficials': [{'name': 'Weidong Han, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Han weidong', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}