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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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 for surgery

Individuals who cannot tolerate MRI scan or PET/CT scan

Trial design

Treatments tested in this trial

  • Advanced Magnetic Resonance Imaging
  • Brain Surgery
  • Electronic Health Record Review
  • Immuno-Positron Emission Tomography Scan
  • Magnetic Resonance Imaging
  • Stereotactic Biopsy
  • Zirconium Zr 89 Crefmirlimab Berdoxam

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator