NCT06922604 Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
| NCT ID | NCT06922604 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | City of Hope Medical Center |
| Condition | Primary Central Nervous System Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2029-01-02 |
Trial Parameters
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Brief 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 Criteria
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 alone is acceptable in secondary CNS lymphoma cases where all of the following criteria are met: 1) brain MRI findings are consistent with CNS lymphoma, 2) the disease has been histologically documented in other sites, 3) the CNS lesions are concomitant with systemic progression, and 4) a brain biopsy would be unadvised per the treating provider. * Cohort 1: Primary CNS lymphoma * Cohort 2: Secondary CNS l