protocolSection identificationModule nctId: NCT06357676, orgStudyIdInfo id: STUDY00025355, secondaryIdInfos id: NCI-2024-01208, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00025355, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Genentech, Inc., descriptionModule briefSummary: This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL., conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: FDG-Positron Emission Tomography, interventions name: Glofitamab, interventions name: Ibrutinib, interventions name: Magnetic Resonance Imaging, interventions name: Obinutuzumab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLT), primaryOutcomes measure: Proportion of participants who achieve a complete response (CR), secondaryOutcomes measure: Incidence of grade 3 or above adverse events (AEs), secondaryOutcomes measure: Proportion of patients treated with tocilizumab (TCZ), secondaryOutcomes measure: Number of doses of TCZ per participant, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of complete response (DOCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Knight Cancer Clinical Trials Hotline, role: CONTACT, phone: 503-494-1080, email: trials@ohsu.edu, contacts name: Stephen E. Spurgeon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False