NCT06650163 · Jonsson Comprehensive Cancer Center
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Incidence of adverse events
Time frame: Up to 1 month
Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.
Zirconium (Zr)-89 crefmirlimab berdoxam uptake
Time frame: Up to 24 hours
Will be determined by standardized uptake value-based quantitative measures relative to CD8+ tumor infiltrating lymphocytes density determined by immunohistochemistry from tumor biopsy samples. Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary. Will correlate immuno-positron emission tomography uptake with cytotoxic T-cell density across all tumor samples. Multivariate cox and log rank tests will be used to compare survival outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN OR =\< 5 X institutional ULN for subjects with Gilberts syndrome
- Albumin \>= 2.5 mg/dL
- Patients with splenic dysfunction or post splenectomy
- Any abnormalities that would be a contraindication to gadolinium-based contrast agent
Where
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations