IGNITE MCL Trial: Glofitamab, Ibrutinib, and Obinutuzumab for Mantle Cell Lymphoma
This study, called IGNITE MCL, is testing a combination of three medicines—glofitamab, ibrutinib, and obinutuzumab—for people with Mantle Cell Lymphoma (MCL). Glofitamab is a type of antibody that helps your immune system fight cancer cells by targeting specific markers (CD3 and CD20) on these cells. The study aims to find out how safe these medicines are together, what side effects they might cause, and how well they work to shrink or get rid of the cancer. You might be able to join if you are 18 or older, have MCL confirmed by specific genetic markers (t(11;14) and/or cyclin D1 overexpression), and can understand and sign the consent form. The study will measure how many participants experience serious side effects and how many achieve a complete response, meaning the cancer is no longer detectable.
- Study design
- This is a Phase Ib/II interventional study, meaning it's an early-stage trial looking at safety and effectiveness. It plans to enroll 27 participants.
- What's involved
- You would take ibrutinib by mouth daily for up to 17 cycles (each cycle is 21 days). You would also receive glofitamab intravenously (through a vein) on specific days during cycles 2 through 13. You will undergo blood sample collection, bone marrow biopsies, CT scans or FDG PET/CT scans, and echocardiograms.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess the proportion of participants who achieve a complete response up to 3 years after starting treatment.
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NCT06357676
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
Recruiting
PHASE1Ages 18+InterventionalTreatmentOHSU Knight Cancer InstituteInvestigator-initiated
~27 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow BiopsyComputed TomographyEchocardiographyFDG-Positron Emission TomographyGlofitamab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLT)
Measured over At start of cycle 2 day 1 to end of Cycle 3 (each cycle is 21 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOregon1
Study leadership
- Stephen E Spurgeon · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Previous MCL-directed treatment. Treatment with corticosteroids (up to 20 mg dexamethasone or equivalent daily) is allowed prior to and during the screening period for patients with aggressive clinical behavior. All steroids used for disease control must be discontinued within 7 days before starting study treatment except for doses ≤ 20 mg per day of prednisone or equivalent. Ongoing steroids as premedications or for cytokine release syndrome (CRS) management are allowed on study
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
History of prior malignancy except for the following:
Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician
Persons with low grade prostate cancer on a watch and wait strategy are eligible
Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer
Adequately treated carcinoma in situ without current evidence of disease
Ongoing hormonal therapy alone for prior malignancy is allowed
Concurrent use of cytotoxic chemotherapy; radiotherapy; immunotherapy; hormone therapy (other than contraceptives, hormone-replacement therapy, or megestrol acetate); and biologic agents (other than hematopoietic growth factors, if clinically indicated and used in accordance with manufacture and Investigator recommendations), unless approved by the investigator
Received systemic immunosuppressive medications (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to obinutuzumab infusion with the exception of those described
Known history of hypersensitivity to
Humanized or murine monoclonal antibodies or products
A CD3 and / or CD20 antibody
Glofitamab
Ibrutinib
Tocilizumab
Current or past history of epilepsy, central nervous system (CNS) vasculitis, and neurodegenerative disease
History of autoimmune disease (e.g., myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with a remote history of, or well controlled, autoimmune disease may be eligible to enroll after consultation with the primary investigator
History of bleeding risks:
Stroke, transient ischaemic attack (TIA),or intracranial hemorrhage within 2 years of first dose of study drug given no remaining neurological deficits
Known bleeding diathesis (e.g., hemophilia or von Willebrand disease)
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months prior to cycle 1 day 1 (C1D1)
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of C1D1
Requires treatment with a strong CYP3A inhibitor/inducer, except for the following:
A plan to modify concurrent CYP3A inhibitor/inducer and/or wash-out periods prior to C1D1
Topical ketoconazole: Based on its low overall bioavailability, there are no restrictions
Concurrent participation in another therapeutic clinical trial
History of confirmed progressive multifocal leukoencephalopathy (PML) or lymphomatous involvement of the CNS
Known or suspected history of hemophagocytic lymphohistiocystosis (HLH)
Evidence of ongoing acute or systemic infections (bacterial, fungal, or viral), or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing, except localized fungal infections of skin or nails. Subjects may be receiving prophylactic antiviral or antibacterial therapies at the discretion of the investigator
Receipt of live vaccine within 4 weeks of enrollment or during study treatment period
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
What this trial measures
- Incidence of dose-limiting toxicities (DLT)At start of cycle 2 day 1 to end of Cycle 3 (each cycle is 21 days)
The incidence and type of DLT will be reported. Descriptive statistics will be used to report AEs.
- Proportion of participants who achieve a complete response (CR)Start of treatment (Cycle 1 Day 1) to date of first CR, documented at any on-treatment or end-of-treatment (EOT) disease assessment, up to 3 years
The proportion of patients that achieve a CR will be reported with 95% exact confidence interval (CI). Response to treatment will be evaluated using positron emission tomography/computed tomography (CT) or CT studies and assessed according to Lugano criteria.