Actively Recruiting
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Led by City of Hope Medical Center · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides documented informed consent
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or approval for exception
- Age 18 years or older
- Karnofsky performance status of 30 or higher
- Histologically confirmed primary or secondary CNS lymphoma with tumor positive for CD20
- Patients not requiring urgent treatment due to bulky or rapidly progressing CNS lymphoma with risk of critical brain failure
- Failed methotrexate-based therapy or ineligible/refuse high-dose methotrexate treatment
- Measurable CNS lymphoma based on MRI or positive CSF or intravitreal fluid cytology
- Fully recovered from acute toxic effects (except alopecia) to grade 1 or better from prior anti-cancer therapy
- Alert and able to participate in full neurological exam
- Adequate blood counts and organ function as specified (neutrophils, platelets, hemoglobin, bilirubin, AST, ALT, creatinine clearance, coagulation parameters)
- Seronegative or stable on therapy for HIV with specific criteria
- Seronegative for active hepatitis B and C with specific testing and monitoring requirements
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception or abstain
- Males must agree to use contraception or abstain and refrain from donating sperm during study and specified periods afterward
- No use of unreliable contraception methods such as periodic abstinence or withdrawal
- Childbearing potential defined as not permanently sterilized or not free from menses for over 1 year (women)
You will not qualify if you...
- Allergy or severe reactions to glofitamab components or murine products
- Prior solid organ transplantation
- Recent treatment with systemic immunotherapeutic agents, glofitamab or CD20 x CD3 bispecific antibodies
- Recent systemic chemotherapy or intrathecal chemotherapy within specified timeframes
- Recent radiotherapy without measurable lesion outside radiation field
- Prior CAR-T therapy within 30 days before study
- Any investigational cancer therapy within 21 days before study
- Use of corticosteroids except for lymphoma symptom control or specific permitted uses
- History of other malignancies affecting study compliance or interpretation except certain treated cancers
- Unstable cardiac disease including recent myocardial infarction and severe heart failure
- Recent major surgery within 4 weeks before study
- Current or past CNS diseases like stroke or epilepsy except CNS lymphoma with exceptions
- History or suspicion of hemophagocytic lymphohistiocytosis
- Clinically significant abnormal electrocardiogram
- Active or recent serious infections or reactivation of latent infections
- Active autoimmune diseases needing immune suppressive treatment except specified controlled conditions
- Significant liver disease including active hepatitis or cirrhosis
- Live attenuated vaccines within 4 weeks before treatment or planned during study until B cells recover
- Suspected active or latent tuberculosis
- History of progressive multifocal leukoencephalopathy
- Pregnant or breastfeeding women or intending pregnancy during study or specified periods afterward
- Any condition that contraindicates participation due to safety concerns or inability to comply with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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