Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 10:18 PM
Study NCT ID:
NCT06922604
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase 1b Study of Glofitamab in CNS Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02019 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 24487 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |