Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 5:48 PM
Study NCT ID:
NCT06792734
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event and dose-limiting toxicity event rates', 'timeFrame': '24 months', 'description': 'The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, B-Cell']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:\n\nWhat are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?\n\nParticipants will:\n\nTake BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight', 'detailedDescription': "This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be age ≥18 years\n* must have a diagnosis of relapsed or refractory mature B cell lymphoma\n* must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)\n* must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* must have a predicted life expectancy of ≥3 months\n* must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566\n\nExclusion Criteria:\n\n* has primary CNS lymphoma\n* has ongoing toxicities from prior anti-cancer treatment \\> Grade 1\n* has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation\n* has received any anti-cancer therapy (including radiation of curative intent) \\<28 days prior to administration of BTM-3566\n* has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).\n* is pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06792734', 'briefTitle': 'Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bantam Pharmaceuticals'}, 'officialTitle': 'Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas', 'orgStudyIdInfo': {'id': 'BTM-3566-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BTM-3566 Treatment', 'description': 'BTM-3566 Oral Solution', 'interventionNames': ['Drug: BTM-3566']}], 'interventions': [{'name': 'BTM-3566', 'type': 'DRUG', 'otherNames': ['BTM-3566 Oral Solution'], 'description': 'Oral Solution', 'armGroupLabels': ['BTM-3566 Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luhua M Wang, MD', 'role': 'CONTACT', 'phone': '713-792-2121'}, {'name': 'Luhua M Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Lori McDermott', 'role': 'CONTACT', 'email': 'lmcdermott@bantampharma.com', 'phone': '1-646-598-4823'}, {'name': 'Meghan Reynolds', 'role': 'CONTACT', 'email': 'mreynolds@bantampharma.com'}], 'overallOfficials': [{'name': 'Zahid Bashir, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bantam Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bantam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}