RecruitingPhase 1NCT06650163

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


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET/CT imaging approach using a radioactive tracer called Zr-89 Crefmirlimab Berdoxam to take pictures of immune activity inside brain tumors — including gliomas, meningiomas, and brain metastases — just before surgery. The goal is to better understand how the immune system responds to brain tumors. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a brain tumor (any grade of glioma, meningioma, or brain metastases) - You are already scheduled for standard surgical tumor removal - You are able to undergo both MRI and PET/CT scanning **You may NOT be eligible if...** - You are under 18 - You are pregnant or breastfeeding - You have a condition that makes surgery unsafe - You cannot tolerate MRI or PET/CT scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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_TESTZirconium Zr 89 Crefmirlimab Berdoxam

Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT06650163


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