Glofitamab + Ibrutinib + Obinutuzumab for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByStephen E. Spurgeon

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with Mantle Cell Lymphoma. It's designed to test the safety and effectiveness of a combination treatment involving glofitamab, ibrutinib, and obinutuzumab. Participants should meet specific health criteria but those details are not provided here.

Participant Groups

The study examines a new therapy combining glofitamab (a bispecific monoclonal antibody), ibrutinib (a kinase inhibitor), and obinutuzumab (another monoclonal antibody) in treating MCL. The trial will assess if this combo is safe, tolerable, and effective against cancer cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (glofitamab, ibrutinib, obinutuzumab)Experimental Treatment9 Interventions

Patients receive ibrutinib PO QD on days 1-21 of cycles 1-17. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients receive glofitamab IV over 2-4 hours on days 8 and 15 of cycle 2 and then on day 1 of cycles 3-13. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV over 4 hours at least 7 days and 24 hours prior to first dose of glofitamab. Additionally, patients undergo echocardiography during screening, bone marrow biopsy on study, and CT scans, FDG PET/CT scans or MRI, and blood sample collection throughout the study.

Glofitamab is already approved in United States for the following indications:

🇺🇸 Approved in United States as COLUMVI for:

Relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL), or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy