Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma (NCT06922604) | Clinical Trial Compass
SuspendedPhase 1
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Stopped: Pending Amendment Approval
United States20 participantsStarted 2025-07-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lymphoma
* Patients must not require urgent treatment initiation due to bulky or rapidly progressing CNS lymphoma that poses risk for impending critical brain failure. This includes \> 5 mm of midline shift, radiographic evidence of impending brain herniation, or clinical evidence of significantly increased intracranial pressure such as papilledema
* Have failed methotrexate-based therapy or are ineligible/refuse high-dose methotrexate treatment (e.g. creatinine clearance \[CrCl\] \< …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently listed as suspended — do you know why enrollment has been paused, and does that affect whether this could ever be an option for me?
2Since this is a Phase 1 trial focused on finding a safe dose, and the primary outcomes are all about serious side effects like severe cytokine release syndrome and grade 4 or 5 toxicities, what does that mean for what's actually known right now about whether this treatment works against CNS lymphoma?
3The trial is specifically tracking serious neurologic toxicities as a primary safety concern — given that I already have lymphoma affecting my central nervous system, how would doctors tell apart a treatment side effect versus my disease getting worse?
4Are there standard treatments for primary or secondary CNS lymphoma that I should consider first, before looking at an early-phase experimental trial like this one?
5If this trial were to reopen and I were a candidate, how would the demands of monitoring for serious side effects like cytokine release syndrome fit into my day-to-day life, and would I need to be hospitalized for parts of the treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of grade 3 or higher non-hematologic toxicity that does not resolve to grade 1 or better within 7 days
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)
2
Incidence of grade 3 or 4 thrombocytopenia associated with grade >= 3 bleeding
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)
3
Incidence of grade 4 neutropenia or grade 4 thrombocytopenia (without clinically significant bleeding) that lasts > 14 days
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)
4
Incidence of grade >= 3 cytokine release syndrome (CRS) not resolving to grade 1 or better within 7 days
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)
5
Incidence of grade 4 CRS
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)
6
Incidence of any emergent grade 3 neurologic toxicity
Timeframe: During first 2 cycles of treatment (cycle length = 21 days)