Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To verify the specificity of Zr-89 crefmirlimab berdoxam CD8+ minibody immunoPET in identifying regions of immune cell activity in human glioma patients using stereotactic image-guided biopsies and multiplexed immunohistochemistry (IHC). EXPLORATORY OBJECTIVE: I. To evaluate the associations between exploratory biomarkers, clinical outcomes, and adverse events which include: Ia. Exploring whether changes in specific magnetic resonance imaging (MRI) parameters correlate with tumor and peripheral blood immune responses; Ib. Assessing the potential change in Zr-89 crefmi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 fo…
Interventions
- ProcedureAdvanced Magnetic Resonance Imaging
Undergo advanced MRI
- ProcedureBrain Surgery
Undergo brain surgery
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureImmuno-Positron Emission Tomography Scan
Undergo immuno-PET
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureStereotactic Biopsy
Undergo stereotactic image-guided biopsy
- Diagnostic Test
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California