Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-31 @ 3:30 PM
Study NCT ID:
NCT04296461
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2020-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A standard 3+3 trial design will be used Welgenaleucel(UWC19) dose escalation cohorts. The planned dose escalation cohort levels for Welgenaleucel (UWC19) are 4, 8, 12, 16 and 20 x10\\^6 CAR-T cells/kg.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '30 days after infusion', 'description': 'A standard 3+3 trial design will be used for Welgenaleucel (UWC19) dose escalation cohorts.The dosing of Welgenaleucel (UWC19) will be divided into 5 cohorts, the subjects will receive Welgenaleucel (UWC19) once on day 14-18 after apheresis.'}, {'measure': 'Dose Limiting Toxicities (DLT)', 'timeFrame': '30 days after infusion', 'description': 'The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19', 'non-Hodgkin lymphoma', 'CAR-T cells'], 'conditions': ['B-cell Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-center Phase 1/2 study with a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHave a primary diagnosis of B cell non-Hodgkin lymphoma\n\n\\- Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), Transformation Follicular Lymphoma (TFL), High grade B-cell Lymphoma (HGBCL), Mantle cell Lymphoma (MANT), Burkitt Lymphoma (BURK), Lymphoblastic Lymphoma\n\n* Chemotherapy-refractory disease, defined as one of more of the following No response to last line of therapy OR Refractory post-autologous stem cell transplant (ASCT)\n* Individuals must have received adequate prior therapy including at a minimum:\n\nanti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for individual with transformed FL must have chemorefractory disease after transformation to DLBCL.\n\n* No active infection of HIV, HTLV and Syphilis\n* Adequate renal function\n* Adequate hepatic function\n* Adequate cardiac function\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given.\n\nExclusion Criteria:\n\nA subject will not be eligible for inclusion in this study if any of the following criteria apply:\n\n* Received allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)\n* Body weight less than 30 kg\n* Pregnant or lactating women.\n* Uncontrolled active infection.\n* History of hepatitis B or hepatitis C infection.\n* Previously treatment with any gene therapy products or cell therapy product in past 28 days.\n* HIV infection.\n* Lymphoma with central nervous system (CNS) involvement\n* Have autoimmune disorders\n* Have active infection or inflammatory disorders\n* Prescreening test results in expansion rate less than 5 folds\n* An allergy to gentamycin and/or streptomycin'}, 'identificationModule': {'nctId': 'NCT04296461', 'briefTitle': 'Study of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'UWELL Biopharma'}, 'officialTitle': 'Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'UBP-PCL-P01-3002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Welgenaleucel (UWC19)', 'description': 'Part I The safety and efficacy of Welgenaleucel (UWC19) will be evaluated in a standard 3+3 dose escalation approach.The planned dose escalation cohort levels for Welgenaleucel (UWC19) are 4, 8, 12, 16 and 20 x10\\^6 CAR-T cells/kg administered intravenously once.', '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': '11490', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ching-Liang Ho, MD', 'role': 'CONTACT'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Cheng-Yi Kuo, PhD', 'role': 'CONTACT', 'email': 'jerry.kuo@uwell.com.tw', 'phone': '+886-2-26972200', 'phoneExt': '202'}], 'overallOfficials': [{'name': 'Ching-Liang Ho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UWELL Biopharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tri-Service General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}