RecruitingPhase 1NCT06922604

Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma

A Phase 1b Study of Glofitamab in CNS Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. 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). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing glofitamab (a bispecific antibody that helps the immune system attack lymphoma cells) combined with a pre-treatment drug called obinutuzumab for people with lymphoma that has spread to the central nervous system (CNS lymphoma — either primary brain lymphoma or cancer that has spread from elsewhere). **You may be eligible if...** - You are 18 or older - You have histologically confirmed CNS lymphoma (primary or secondary) - Your tumor tests positive for the CD20 protein - Your functional status is adequate (Karnofsky score ≥ 30) - Tumor tissue from a prior biopsy is available (or exceptions can be made) **You may NOT be eligible if...** - Your lymphoma does not express CD20 - You have had prior treatment with certain bispecific antibodies or CAR-T therapy - You have active autoimmune disease or serious infections - 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 CSF and blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

BIOLOGICALGlofitamab

Given IV

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo brain MRI

BIOLOGICALObinutuzumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06922604


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