NCT06922604

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

A Phase 1b Study of Glofitamab in CNS Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the safety of glofitamab with obinutuzumab pre-treatment in patients with primary and secondary CNS lymphoma. SECONDARY OBJECTIVES: I. To estimate the overall response rate of glofitamab with obinutuzumab pre-treatment in primary and secondary CNS lymphoma. II. To estimate the complete response rate, duration of response, duration of complete response, progression-free survival, event-free survival, and overall survival of glofitamab with obinutuzumab pre-treatment in primary and secondary CNS lymphoma. EXPLORATORY OBJECTIVES: I. To evaluate the degree to which glofitamab crosses the blood brain barrier (BBB) in CNS lymphoma and define biomarkers of response and toxicity to treatment. II. To assess the utility of tocilizumab to address cytokine release syndrome in CNS lymphoma subjects treated with glofitamab. III. To assess the utility of corticosteroids to address immune effector cell-associated neurotoxicity syndrome in CNS lymphoma subjects treated with glofitamab. OUTLINE: Patients receive obinutuzumab intravenously (IV) on day 1 of cycle 1 and glofitamab IV over 2-4 hours on days 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT at screening and cerebrospinal fluid (CSF) and blood sample collection, brain magnetic resonance imaging (MRI) throughout the study. Patients with secondary CNS lymphoma also undergo CT or PET/CT throughout the study. Additionally, patients with baseline CSF involvement, may undergo lumbar puncture throughout the study. After completion of study treatment, patients are followed up at 30 days and at 3, 6, 9, 12, 18, and 24 months.

Conditions

• Primary Central Nervous System Lymphoma
• Secondary Central Nervous System Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo CSF and blood sample collection
PROCEDURE	Computed Tomography	Undergo CT or PET/CT
BIOLOGICAL	Glofitamab	Given IV
PROCEDURE	Lumbar Puncture	Undergo lumbar puncture
PROCEDURE	Magnetic Resonance Imaging	Undergo brain MRI
BIOLOGICAL	Obinutuzumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2025-07-30
• Primary completion: 2029-01-02
• Completion: 2029-01-02
• First posted: 2025-04-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study