NCT06650163

Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors

Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 crefmirlimab berdoxam uptake in tumor tissue and correlation with CD8 infiltrate in tumor tissue; Ic. Explore the correlation of visual and semi-quantitative Zr-89 crefmirlimab berdoxam PET measurements with clinical outcome. OUTLINE: Patients receive Zr-89 crefmirlimab berdoxam intravenously (IV) over 5-10 minutes 3 days prior to scheduled surgical resection. Approximately 24 hours after receiving Zr-89 crefmirlimab berdoxam, patients undergo immuno-PET scans. Patients then undergo scheduled standard of care surgical resection of the brain tumor and brain biopsy. Additionally, patients undergo advanced physiologic and metabolic magnetic resonance imaging (MRI) and MRI prior to surgery on study. After completion of study treatment, patients are followed up until death.

Conditions

• Glioma
• Malignant Brain Neoplasm
• Meningioma
• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
PROCEDURE	Advanced Magnetic Resonance Imaging	Undergo advanced MRI
PROCEDURE	Brain Surgery	Undergo brain surgery
OTHER	Electronic Health Record Review	Ancillary studies
PROCEDURE	Immuno-Positron Emission Tomography Scan	Undergo immuno-PET
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Stereotactic Biopsy	Undergo stereotactic image-guided biopsy
DIAGNOSTIC_TEST	Zirconium Zr 89 Crefmirlimab Berdoxam	Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET

Timeline

• Start date: 2024-12-05
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2024-10-21
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study