Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-11 @ 9:34 AM
Study NCT ID:
NCT03811457
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2019-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'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'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The adverse events associated with CAR T cell product infusions are assessed.', 'timeFrame': '30 days', 'description': 'The type, frequency, severity, and duration of adverse events will be summarized'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T cell, CD19, Lymphoma, Leukemia'], 'conditions': ['Lymphoma Leukemia']}, 'descriptionModule': {'briefSummary': "B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies\n* Absolute lymphocyte count, ALC )≧600/μl\n* HIV, HTLV, Syphilis negative\n* GPT ≦200 U/L\n* Cr ≦221 umol/L\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Voluntary informed consent is given.\n\nExclusion Criteria:\n\n* Body weight \\< 20Kg\n* Pregnant women.\n* Uncontrolled active infection.\n* Active hepatitis B or hepatitis C infection.\n* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n* Previously treatment with any gene or cell therapy products.\n* Any uncontrolled active medical disorder that would preclude participation as outlined.\n* Expected survival\\< 12 weeks\n* Received investigational drug or device within 30 days pre-trial;\n* Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.'}, 'identificationModule': {'nctId': 'NCT03811457', 'briefTitle': 'Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'UWELL Biopharma'}, 'officialTitle': 'Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma', 'orgStudyIdInfo': {'id': 'UCAR019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Welgenaleucel (UWC19)', 'description': 'The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times', 'interventionNames': ['Genetic: Welgenaleucel']}], 'interventions': [{'name': 'Welgenaleucel', 'type': 'GENETIC', 'otherNames': ['UWC19'], 'description': 'Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.', 'armGroupLabels': ['Welgenaleucel (UWC19)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '252000', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Liaocheng People Hospital', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}], 'overallOfficials': [{'name': 'Cheng-Yi Kuo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UWELL Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UWELL Biopharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Liaocheng People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}