Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors

NCT06650163 | Recruiting Phase 1 DMC FDA Drug

• 5 other identifiers: 24-000877NCI-2024-08388P30CA016042P50CA211015R01CA267726
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Malignant Brain Neoplasm; Meningioma; Metastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.

  Up to 1 month

• Zirconium (Zr)-89 crefmirlimab berdoxam uptake

  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.

  Up to 24 hours

Study Arms (1)

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

EXPERIMENTAL

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.

Procedure: Advanced Magnetic Resonance Imaging; Procedure: Brain Surgery; Other: Electronic Health Record Review; Procedure: Immuno-Positron Emission Tomography Scan; Procedure: Magnetic Resonance Imaging; Procedure: Stereotactic Biopsy; Diagnostic Test: Zirconium Zr 89 Crefmirlimab Berdoxam

Interventions

Advanced Magnetic Resonance Imaging PROCEDURE

Undergo advanced MRI

Also known as: AMRI

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Stereotactic Biopsy PROCEDURE

Undergo stereotactic image-guided biopsy

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Zirconium Zr 89 Crefmirlimab Berdoxam DIAGNOSTIC_TEST

Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET

Also known as: 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2C, Zirconium Zr 89-Df-Crefmirlimab, Zirconium Zr 89-Df-IAB22M2C, Zirconium Zr-89 Crefmirlimab Berdoxam

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Brain Surgery PROCEDURE

Undergo brain surgery

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Electronic Health Record Review OTHER

Ancillary studies

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Immuno-Positron Emission Tomography Scan PROCEDURE

Undergo immuno-PET

Also known as: Immuno-PET Scan

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Meningioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert M Prins

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sichen Li

CONTACT

310-592-9091; sichenli@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)