RecruitingPhase 2NCT06054776

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

40 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. 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). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — acalabrutinib, obinutuzumab, and glofitamab — for people with mantle cell lymphoma (a type of blood cancer) whose cancer has come back or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with mantle cell lymphoma confirmed by a specialist - Your lymphoma has relapsed or is no longer responding after at least one prior treatment - You are 18 years or older - Your general health is reasonably good (ECOG score 2 or less) - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - You have certain serious infections (HIV, active hepatitis B or C) - You have severe heart problems or uncontrolled other medical conditions - You have had certain prior treatments that would overlap with the study drugs - 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

DRUGAcalabrutinib

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsies

PROCEDUREComputed Tomography

Undergo PET/CT or CT

PROCEDUREEchocardiography

Undergo ECHO

BIOLOGICALGlofitamab

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

BIOLOGICALObinutuzumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06054776


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