Recruiting
Phase 1

Zr-89 Crefmirlimab

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06650163

Conditions

Glioma

Malignant Brain Neoplasm

Meningioma

Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Advanced Magnetic Resonance Imaging

Brain Surgery

Electronic Health Record Review

Immuno-Positron Emission Tomography Scan

Magnetic Resonance Imaging

Study Details

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

Study ID

NCT06650163

Start date

Dec 5, 2024

Status verified date

Feb, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)

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.

Interventions

Advanced Magnetic Resonance Imaging

Undergo advanced MRI

Brain Surgery

Undergo brain surgery

Electronic Health Record Review

Ancillary studies

Immuno-Positron Emission Tomography Scan

Undergo immuno-PET

Magnetic Resonance Imaging

Undergo MRI

Stereotactic Biopsy

Undergo stereotactic image-guided biopsy

Zirconium Zr 89 Crefmirlimab Berdoxam

Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 1 month ]
  • Zirconium (Zr)-89 crefmirlimab berdoxam uptake [ Time Frame: Up to 24 hours ]

Central Contacts and Locations

Central contacts

Sichen Li

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

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Sichen Li

310-794-5663sichenli@mednet.ucla.edu

Principal Investigator:

Robert M. Prins, PhD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-02-05.