Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-16 @ 6:51 AM
Study NCT ID:
NCT03266692
Status:
TERMINATED
Last Update Posted:
2020-03-30
First Post:
2017-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of ACTR087 in combination with SEA-BCMA', 'timeFrame': '28 days', 'description': 'Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values'}, {'measure': 'Determination of recommended Phase 2 dosing regimen', 'timeFrame': '52 weeks', 'description': 'Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values'}], 'secondaryOutcomes': [{'measure': 'Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '21 days', 'description': 'Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values'}, {'measure': 'Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)', 'timeFrame': '52 weeks'}, {'measure': 'Anti-myeloma activity as measured by duration of response', 'timeFrame': '52 weeks'}, {'measure': 'Anti-myeloma activity as measured by progression-free survival', 'timeFrame': '52 weeks'}, {'measure': 'Anti-myeloma activity as measured by overall survival', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of ACTR087 phenotype and function as measured by flow cytometry', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration', 'timeFrame': '52 weeks', 'description': 'Levels of inflammatory markers, cytokines/chemokines'}, {'measure': 'SEA-BCMA PK', 'timeFrame': '52 weeks', 'description': 'SEA-BCMA plasma concentration'}, {'measure': 'Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration', 'timeFrame': '52 weeks', 'description': 'Incidence of ADAs to SEA-BCMA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCMA', 'SEA-BCMA', 'B Cell Maturation Antigen', 'ACTR', 'ACTR087', 'T cell', 'T cell product', 'relapsed', 'refractory', 'multiple myeloma', 'adoptive T cells', 'autologous', 'gene therapy', 'cell therapy'], 'conditions': ['Multiple Myeloma', 'Multiple Myeloma in Relapse', 'Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent obtained prior to study procedures\n* Histologically- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease\n* Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible.\n* Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)\n* ECOG 0 or 1\n* Life expectancy of at least 6 months\n* Absolute neutrophil (ANC) count greater than 1000/ µL\n* Platelet count greater than 50,000/µL\n* Estimated GFR \\>30mL/min/1.73m2\n\nExclusion Criteria:\n\n* Known active central nervous system (CNS) involvement by MM\n* Systemic rheumatic or autoimmune diseases or acute or chronic infections\n* Uncontrolled thromboembolic events or recent severe hemorrhage\n* Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)\n* Prior treatment as follows:\n\n * T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment\n * Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment\n * Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment\n * Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy\n * Prior BCMA-directed investigational agents at any time\n * Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03266692', 'briefTitle': 'Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cogent Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination With SEA-BCMA, a Monoclonal Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'ATTCK-17-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTR087 in combination with SEA-BCMA', 'interventionNames': ['Biological: ACTR087', 'Biological: SEA-BCMA']}], 'interventions': [{'name': 'ACTR087', 'type': 'BIOLOGICAL', 'description': 'Autologous T cell product', 'armGroupLabels': ['ACTR087 in combination with SEA-BCMA']}, {'name': 'SEA-BCMA', 'type': 'BIOLOGICAL', 'description': 'B-cell maturation antigen (BCMA)-directed antibody', 'armGroupLabels': ['ACTR087 in combination with SEA-BCMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '46327', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Blood and Marrow Transplantation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Jessica Sachs, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cogent Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cogent Biosciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seagen Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}