RecruitingPhase 1Phase 2NCT06357676

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial

Integrated Glofit and Ibrutinib as Novel Immune Therapy Evaluation in Treatment-Naive Mantle Cell Lymphoma (IGNITE MCL): A Phase Ib/II Study of Glofitamab Plus Ibrutinib With Obinutuzumab Pretreatment in MCL Patients ≥ 65 or Ages 18-64 With High-Risk Features


Sponsor

OHSU Knight Cancer Institute

Enrollment

27 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (IGNITE MCL) is testing a combination of three drugs — glofitamab, ibrutinib, and obinutuzumab — to treat a type of blood cancer called Mantle Cell Lymphoma (MCL). The goal is to see if this combination works better than standard treatments, especially for younger patients with high-risk disease. **You may be eligible if...** - You are 18–64 years old with high-risk MCL features, such as certain gene mutations (p53, KMT2D, NOTCH1, etc.), a blastoid or aggressive cell appearance, or complex chromosomal abnormalities - OR you are 65 or older with MCL who cannot tolerate intensive stem cell transplant treatment - Your MCL has been confirmed by biopsy showing the characteristic chromosome change (t(11;14)) or cyclin D1 overexpression - You have not previously been treated with ibrutinib or other BTK inhibitors **You may NOT be eligible if...** - You have previously received ibrutinib, acalabrutinib, or similar drugs - You have uncontrolled heart rhythm problems (atrial fibrillation) or are on blood thinners that cannot be safely paused - You have active central nervous system (brain) lymphoma involvement - You have serious liver, kidney, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT scan or FDG PET/CT

PROCEDUREEchocardiography

Undergo echocardiography

PROCEDUREFDG-Positron Emission Tomography

Undergo FDG PET/CT

BIOLOGICALGlofitamab

Given IV

DRUGIbrutinib

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALObinutuzumab

Given IV


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT06357676


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