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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Robert M Prins · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-05

Primary Completion

2027-01-31

Completion

2028-01-31

FDA Drug

Yes

Countries

• United States

Study Locations