Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
- ✕ Pregnant or breast-feeding women
- ✕ Serum creatinine OR measured or calculated creatinine clearance (Glomerular filtration rate \[GFR\] can be use in place of creatinine or creatinine clearance \[CrCl\]) =\< 1.5 X institutional upper limit of normal (ULN) OR \>= 60mL/min for subjects with creatinine levels \> 1.5 X institutional ULN
- ✕ Creatinine clearance should be calculated per institutional standard
- ✕ Serum total bilirubin: =\< 1.5 X institutional ULN OR direct bilirubin =\< institutional ULN for subjects with total bilirubin levels \> 1.5 institutional ULN
Where it's recruiting
Los Angeles
Source: ClinicalTrials.gov · NCT06650163 · last updated 2026-02-05