Actively Recruiting
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
Led by OHSU Knight Cancer Institute · Updated on 2026-01-30
27
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide signed informed consent
- Diagnosed with mantle cell lymphoma confirmed by specific genetic markers or protein expression
- Aged 18 to 64 with high-risk disease features such as certain mutations, aggressive cell types, complex karyotype, high Ki67, high MIPI score, or high p53 expression
- Aged 65 or older regardless of risk features
- No prior systemic treatments for mantle cell lymphoma
- Presence of measurable lymphadenopathy or extranodal lymphoma
- Willing to provide biosamples for testing
- ECOG performance status of 2 or less
- Absolute neutrophil count of at least 1.0 x 10^9/L
- Platelet count of at least 100 x 10^9/L or 50 x 10^9/L if bone marrow involved
- Liver enzymes (ALT and AST) less than or equal to 3 times upper limit of normal
- Total bilirubin less than or equal to 1.5 times upper limit of normal unless due to Gilbert's syndrome or non-liver cause
- Estimated creatinine clearance at least 50 mL/min
- Negative hepatitis B surface antigen and hepatitis C antigen tests
- Negative HIV test or controlled HIV with undetectable viral load and CD4 count of at least 200/µL
- Able and willing to participate in all study procedures including swallowing capsules
- Women of childbearing potential must have negative pregnancy test and use contraception during and after treatment
- Men producing sperm must use contraception during and after treatment
- Agree to avoid breastfeeding and sperm or egg donation during and after treatment
You will not qualify if you...
- Prior treatments specifically for mantle cell lymphoma, except limited steroid use as allowed
- Significant heart disease such as recent heart attack, uncontrolled arrhythmia, or severe heart failure
- History of other cancers unless treated, inactive for more than 2 years, and low risk of recurrence
- Current use of chemotherapy, radiotherapy, immunotherapy, hormone therapy (except contraceptives or hormone replacement), or biologic agents unless approved
- Use of systemic immunosuppressive medications within 2 weeks prior to obinutuzumab infusion except as described
- Known allergies to monoclonal antibodies, glofitamab, ibrutinib, or tocilizumab
- History of epilepsy, CNS vasculitis, or neurodegenerative diseases
- History of autoimmune diseases unless well controlled and approved
- Recent history of bleeding disorders or risks including stroke, bleeding diseases, or recent gastrointestinal ulcers
- Use of warfarin or similar anticoagulants within 7 days before first study dose
- Need for strong CYP3A inhibitors or inducers without planned modification
- Participation in another therapeutic clinical trial
- History of progressive multifocal leukoencephalopathy or lymphoma in the central nervous system
- Known or suspected hemophagocytic lymphohistiocytosis
- Active infections requiring hospitalization or IV antibiotics within 4 weeks except localized fungal infections
- Receipt of live vaccines within 4 weeks before or during treatment
- Any serious illness or organ dysfunction that may risk safety or interfere with treatment or study outcomes
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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