Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05722418
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2022-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(Part A) Number of patients with dose limiting toxicities (DLT)', 'timeFrame': '28 days', 'description': 'Number of patients with DLTs during the 28 days following the first administration of CB-011.'}, {'measure': '(Part B) Overall Response Rate (ORR)', 'timeFrame': '12 Months', 'description': 'The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CaMMouflage', 'Allogeneic', 'Multiple Myeloma', 'Relapse Refractory Multiple Myeloma', 'CAR-T Cells', 'BCMA', 'Cell Therapy', 'Cellular Immuno-therapy', 'CB11A', 'CB-011', 'CB-011A', 'CAR-T', 'Anti BCMA', 'ALLO CAR T'], 'conditions': ['Relapsed/Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)\n2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.\n3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.\n4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T cell therapy directed at any target.\n2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.\n3. Allogeneic stem cell transplant within 6 months before lymphodepletion.\n4. Known active or prior history of CNS involvement.\n5. Stroke or seizure within 6 months of signing ICF.\n6. Seropositive for or history of human immunodeficiency virus.\n7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.\n8. Hepatitis B infection.\n9. Hepatitis C infection.\n10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.'}, 'identificationModule': {'nctId': 'NCT05722418', 'acronym': 'CaMMouflage', 'briefTitle': 'CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Caribou Biosciences, Inc.'}, 'officialTitle': 'A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)', 'orgStudyIdInfo': {'id': 'CB11A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CB-011', 'description': '* Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design.\n* Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A', 'interventionNames': ['Biological: CB-011']}], 'interventions': [{'name': 'CB-011', 'type': 'BIOLOGICAL', 'otherNames': ['Cyclophosphamide', 'Fludarabine'], 'description': 'CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion', 'armGroupLabels': ['CB-011']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luciano Costa, MD', 'role': 'CONTACT', 'email': 'ljcosta@uabmc.edu', 'phone': '205-975-3371'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rona Wang', 'role': 'CONTACT', 'email': 'deng.wang@cuanschutz.edu', 'phone': '303-724-2703'}, {'name': 'Natalie Pfenning', 'role': 'CONTACT', 'email': 'natalie.pfenning@cuanschutz.edu', 'phone': '303-724-9562'}, {'name': 'Daniel Sherbenou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CU Anschutz Medical Campus, Anshutz Cancer Pavillion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jay Spiegel, MD', 'role': 'CONTACT', 'email': 'Spiegelj@med.miami.edu', 'phone': '305-243-0372'}, {'name': 'Jay Spiegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Walton-Robbins', 'role': 'CONTACT', 'email': 'Ashley.robbins@uky.edu', 'phone': '589-218-1758'}, {'name': 'Gregory Monohan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky/ Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oncology Clinical Research Referral Office', 'role': 'CONTACT', 'email': 'oncologyresearchreferral@hmhn.org', 'phone': '551-996-1777'}, {'name': 'David Siegal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hackensack Meridian John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adriana Rossi, MD', 'role': 'CONTACT', 'email': 'adriana.rossi@mssm.edu', 'phone': '917-828-3905'}, {'name': 'Adriana Rossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sham Mailankody, MBBS', 'role': 'CONTACT', 'email': 'cart@mskcc.org', 'phone': '646-608-2091'}, {'name': 'Sham Mailankody, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Bumgarner', 'role': 'CONTACT', 'email': 'Kelly.Bumgarner@atriumhealth.org'}, {'name': 'Manisha Bhutani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Fisher', 'role': 'CONTACT', 'email': 'Matthew.Fister@Duke.edu', 'phone': '919-668-1028'}, {'name': 'Cristina Gasparetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Health System (DUHS)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Doug Hart', 'role': 'CONTACT', 'email': 'douglas.hart@usoncology.com'}, {'name': 'James Essell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncology Hematology Care, Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'Canceranswer@ccf.org', 'phone': '216-444-7923'}, {'name': 'Faiz Anwer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesus Berdeja, MD', 'role': 'CONTACT', 'email': 'jberdeja@tnonc.com', 'phone': '844-482-4812'}, {'name': 'Taylor Peach', 'role': 'CONTACT', 'email': 'tpeach@tnonc.com', 'phone': '629-292-7183'}, {'name': 'Jesus Berdeja, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcella Aguilar', 'role': 'CONTACT', 'email': 'Marcella.Aguilar@utsouthwestern.edu'}, {'name': 'Larry Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Collind Boyington', 'role': 'CONTACT', 'email': 'collind.boyington@HCI.UTAH.EDU', 'phone': '801-587-4779'}, {'name': 'Douglas Sborov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huntsman Cancer Institute, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johanna Biamonte', 'role': 'CONTACT', 'email': 'jbiamonte@vcu.edu', 'phone': '804-628-1896'}, {'name': 'William Clark, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle King', 'role': 'CONTACT', 'email': 'daking@mcw.edu', 'phone': '414-805-9334'}, {'name': 'Binod Dhakal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Froedtert and the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Caribou Biosciences', 'role': 'CONTACT', 'email': 'clinicaltrials@cariboubio.com', 'phone': '510-982-6030', 'phoneExt': '3'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caribou Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}