Imaging brain tumors using a targeted radioimmunoconjugate and PET scans
Official title: Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors
Run by Jonsson Comprehensive Cancer Center · NCT06650163 · Data updated 2026-11-12
This study is testing a new imaging method using a special drug to see if it can help identify immune cells in patients with brain tumors before they have surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | crefmirlimab |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | December 5, 2024 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT06650163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a documented diagnosis of resectable brain tumors such as gliomas or meningiomas.
✕Probably not a fit
Patients under 18, those not medically cleared for surgery, or individuals unable to tolerate MRI or PET scans may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I trial evaluates the effectiveness of zirconium (Zr)-89 crefmirlimab berdoxam in identifying immune cell activity in patients with resectable brain tumors. The study aims to verify the specificity of this radioimmunoconjugate in detecting CD8+ tumor infiltrating lymphocytes through immuno-positron emission tomography (PET) imaging. Patients will receive the Zr-89 crefmirlimab berdoxam intravenously before undergoing PET scans and standard surgical tumor resection. The trial also explores correlations between imaging results, immune responses, and clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to assess immune responses in brain tumors, potentially improving surgical outcomes.
How similar studies have gone: While the use of immuno-PET imaging is a novel approach in this context, similar studies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Robert M Prins — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Sichen Li
- Email: sichenli@mednet.ucla.edu
- Phone: 310-592-9091
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.