Imaging brain tumors using a targeted radioimmunoconjugate and PET scans

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

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: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jonsson Comprehensive Cancer Center (other)
• Drugs / interventions: crefmirlimab
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06650163 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of resectable brain tumors such as gliomas or meningiomas.

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.

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 performed: While the use of immuno-PET imaging is a novel approach in this context, similar studies have shown promise in other cancer types.

Eligibility 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 this trial is running

Los Angeles, California

• 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

Conditions: Glioma, Malignant Brain Neoplasm, Meningioma, Metastatic Malignant Neoplasm in the Brain