A Phase 1b Study of Glofitamab in CNS Lymphoma
City of Hope Medical Center
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.
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Karnofsky performance status (KPS) ≥ 30 * Histologically confirmed primary or secondary CNS lymphoma. Tumor must be positive for CD20 by immunohistochemistry or flow cytometry on the most recent biopsy. Neuroimaging al…
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
Location
- City of Hope Medical CenterDuarte, California