TheranosticTrials.org

Clinical Trial · NCT06650163

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

Overview

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.

Sponsor

Jonsson Comprehensive Cancer Center (UCLA)

Phase

Phase 1

Contacts

Sichen Li (CONTACT)

sichenli@mednet.ucla.edu

310-592-9091

Robert M Prins (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06650163

Drug / Compound

crefmirlimab berdoxam

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DFO

Eligibility

Inclusion

  • * Male or female \>= 18 years of age
  • The participant is scheduled for standard of care surgical tumor resection
  • Documentation of a diagnosis of brain tumor including brain metastases, any grade of gliomas and meningiomas
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

Exclusion

  • 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
  • Individuals who cannot tolerate MRI scan or PET/CT scan
  • * Male or female \< 18 years of age
  • Not medically cleared for surgery
  • Pregnant or breast-feeding women

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

Loading…