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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure, Other
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Sichen Li
sichenli@mednet.ucla.edu
310-592-9091
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 20
Treatments
Experimental: Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Patients receive Zr-89 crefmirlimab berdoxam 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 MRI and MRI prior to surgery.
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov