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.
Male or female >= 18 years of age
Documentation of a diagnosis of brain tumor including brain metastases, any grade of gliomas and meningiomas
The participant is scheduled for standard of care surgical tumor resection
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Male or female < 18 years of age
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Not medically cleared for surgery
Individuals who cannot tolerate MRI scan or PET/CT scan
Single group
Advanced Magnetic Resonance Imaging
Procedure/SurgeryUndergo advanced MRI
Brain Surgery
Procedure/SurgeryUndergo brain surgery
Electronic Health Record Review
Other interventionAncillary studies
Immuno-Positron Emission Tomography Scan
Procedure/SurgeryUndergo immuno-PET
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Stereotactic Biopsy
Procedure/SurgeryUndergo stereotactic image-guided biopsy
Zirconium Zr 89 Crefmirlimab Berdoxam
Diagnostic testUndergo Zirconium Zr 89 Crefmirlimab Berdoxam PET
Incidence of adverse events
Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.
Zirconium (Zr)-89 crefmirlimab berdoxam uptake
Will be determined by standardized uptake value-based quantitative measures relative to CD8+ tumor infiltrating lymphocytes density determined by immunohistochemistry from tumor biopsy samples. Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary. Will correlate immuno-positron emission tomography uptake with cytotoxic T-cell density across all tumor samples. Multivariate cox and log rank tests will be used to compare survival outcomes.
Click on the lead sponsor to view all of their trials.
Jonsson Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
