RecruitingPhase 2NCT07003295

Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy


Sponsor

National Cancer Institute (NCI)

Enrollment

20 participants

Start Date

Aug 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in 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) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing glofitamab — a cancer drug that helps the immune system attack lymphoma cells — for people with mantle cell lymphoma (a type of blood cancer) whose disease has come back or stopped responding after receiving CAR-T cell therapy. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma that has relapsed or is not responding to treatment - You have previously received CAR-T cell therapy targeting CD19 and have also received (or failed) a BTK inhibitor drug - You have at least one measurable tumor on a scan - You are in reasonably good health (ECOG 0–2) - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - You have not had prior CAR-T therapy targeting CD19 - You have not tried or failed a BTK inhibitor - You have active, uncontrolled infections (including HIV or hepatitis B/C) - You are pregnant or breastfeeding - You have serious heart, liver, or kidney problems 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

PROCEDUREComputed Tomography

Undergo PET/CT

BIOLOGICALGlofitamab

Given IV

BIOLOGICALObinutuzumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(5)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07003295


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