Actively Recruiting
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence and change in CD8 positive (+) tumor infiltrating lymphocytes (TIL) cells. Identifying the presence and changes in CD8+ cells can be challenging, particularly for participants with central nervous system (CNS) tumors, and usually requires invasive procedures such as repeat tissue biopsies, which may not accurately represent the immune status of the entire tumor. Zr-89 crefmirlimab berdoxam is known as a radioimmunoconjugate which consists of a radiolabeled anti-CD8+ minibody whose uptake can be imaged with PET. Upon administration, Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8+ cells. This enables PET imaging and may detect CD8+ T-cell distribution and activity and may help determine the patient's response to cancer immunotherapeutic agents more accurately. Giving Zr-89 crefmirlimab berdoxam along with undergoing immuno-PET imaging may work better at identifying immune cell activity in patients with resectable brain tumors.
CONDITIONS
Official Title
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Have a diagnosis of brain tumor including brain metastases, any grade of gliomas, or meningiomas
- Scheduled for standard of care surgical tumor resection
- Able to provide written informed consent (or legally acceptable representative can consent)
You will not qualify if you...
- Younger than 18 years of age
- Have any condition or abnormality that may compromise safety or data quality according to the investigator
- Not medically cleared for surgery
- Unable to tolerate MRI or PET/CT scans
- Pregnant or breast-feeding
- Serum creatinine above 1.5 times the institutional upper limit of normal (ULN) or creatinine clearance below 60 mL/min if creatinine is elevated
- Serum total bilirubin above 1.5 times ULN or direct bilirubin above ULN if total bilirubin is elevated
- Elevated AST or ALT more than 2.5 times ULN (or 5 times ULN for Gilbert's syndrome)
- Albumin level below 2.5 mg/dL
- Have splenic dysfunction or have had their spleen removed
- Any contraindications to gadolinium-based contrast agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
S
Sichen Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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