Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 3:25 PM
Study NCT ID:
NCT04806035
Status:
TERMINATED
Last Update Posted:
2024-07-31
First Post:
2021-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619007', 'term': 'ublituximab'}, {'id': 'C549677', 'term': 'LFB-R603'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Strategic/Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RP2D', 'timeFrame': 'Up to 24 months', 'description': 'To determine the recommended Phase 2 dose (RP2D)'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'Up to 24 months', 'description': 'To evaluate the overall response rate (ORR) of TG-1801'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CLL', 'SLL', "Richter's Transformation", 'Indolent Lymphoma', 'Follicular Lymphoma', 'Marginal Zone Lymphoma', 'Aggressive Lymphoma', 'DLBCL', 'Mediastinal Large B-cell Lymphoma', 'MCL']}, 'referencesModule': {'references': [{'pmid': '35538512', 'type': 'DERIVED', 'citation': 'Chauchet X, Cons L, Chatel L, Daubeuf B, Didelot G, Moine V, Chollet D, Malinge P, Pontini G, Masternak K, Ferlin W, Buatois V, Shang L. CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. Exp Hematol Oncol. 2022 May 10;11(1):26. doi: 10.1186/s40164-022-00279-w.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy\n* Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)\n* Treatment Status:\n\n 1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)\n 2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT\n 3. CLL subjects: relapsed to or refractory after at least two prior standard therapies\n* Measurable disease defined as:\n\n 1. NHL (including SLL): at least 1 measurable disease lesion \\> 1.5 centimeters (cm)\n 2. CLL: at least 1 measurable disease lesion\n\nExclusion Criteria:\n\n* Prior therapy with any agent blocking the CD47/SIRPĪ± pathway or any previous CD19 targeting therapy,\n* Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.\n* Prior autologous stem cell transplant (SCT) within 6 months."}, 'identificationModule': {'nctId': 'NCT04806035', 'briefTitle': 'Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'TG-1801-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: TG-1801', 'description': 'TG-1801 Single Agent\n\nAs per protocol v3.0, Cohort A is no longer enrolling.', 'interventionNames': ['Biological: TG-1801']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: TG-1801', 'description': 'TG-1801 Single Agent, escalating doses', 'interventionNames': ['Biological: TG-1801']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C: TG-1801 + Ublituximab', 'description': 'TG-1801 in combination with ublituximab\n\nAs per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.', 'interventionNames': ['Biological: TG-1801', 'Biological: Ublituximab']}], 'interventions': [{'name': 'TG-1801', 'type': 'BIOLOGICAL', 'otherNames': ['NI-1701'], 'description': 'It is a bispecific, first-in-class, CD47 and CD19 antibody', 'armGroupLabels': ['Cohort A: TG-1801', 'Cohort B: TG-1801', 'Cohort C: TG-1801 + Ublituximab']}, {'name': 'Ublituximab', 'type': 'BIOLOGICAL', 'otherNames': ['TG-1101', 'LFB-R603'], 'description': 'recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks', 'armGroupLabels': ['Cohort C: TG-1801 + Ublituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics Investigational Trial Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TG Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}