Trial Title:
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients with Resectable Brain Tumors
NCT ID:
NCT06650163
Condition:
Glioma
Malignant Brain Neoplasm
Meningioma
Metastatic Malignant Neoplasm in the Brain
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Meningioma
Deferoxamine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Advanced Magnetic Resonance Imaging
Description:
Undergo advanced MRI
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Other name:
AMRI
Intervention type:
Procedure
Intervention name:
Brain Surgery
Description:
Undergo brain surgery
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Intervention type:
Procedure
Intervention name:
Immuno-Positron Emission Tomography Scan
Description:
Undergo immuno-PET
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Other name:
Immuno-PET Scan
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Stereotactic Biopsy
Description:
Undergo stereotactic image-guided biopsy
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Intervention type:
Diagnostic Test
Intervention name:
Zirconium Zr 89 Crefmirlimab Berdoxam
Description:
Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET
Arm group label:
Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)
Other name:
89Zr-Crefmirlimab Berdoxam
Other name:
89Zr-Desferrioxamine-IAB22M2C
Other name:
89Zr-Df-Crefmirlimab
Other name:
89Zr-Df-IAB22M2C
Other name:
Zirconium Zr 89-Df-Crefmirlimab
Other name:
Zirconium Zr 89-Df-IAB22M2C
Other name:
Zirconium Zr-89 Crefmirlimab Berdoxam
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To verify the specificity of Zr-89 crefmirlimab berdoxam CD8+ minibody immunoPET in
identifying regions of immune cell activity in human glioma patients using stereotactic
image-guided biopsies and multiplexed immunohistochemistry (IHC).
EXPLORATORY OBJECTIVE:
I. To evaluate the associations between exploratory biomarkers, clinical outcomes, and
adverse events which include:
Ia. Exploring whether changes in specific magnetic resonance imaging (MRI) parameters
correlate with tumor and peripheral blood immune responses; Ib. Assessing the potential
change in Zr-89 crefmirlimab berdoxam uptake in tumor tissue and correlation with CD8
infiltrate in tumor tissue; Ic. Explore the correlation of visual and semi-quantitative
Zr-89 crefmirlimab berdoxam PET measurements with clinical outcome.
OUTLINE:
Patients receive Zr-89 crefmirlimab berdoxam intravenously (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 magnetic resonance imaging (MRI) and
MRI prior to surgery on study.
After completion of study treatment, patients are followed up until death.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Contact:
Last name:
Sichen Li
Phone:
310-794-5663
Email:
sichenli@mednet.ucla.edu
Contact backup:
Last name:
Robert M. Prins, PhD
Start date:
November 30, 2024
Completion date:
January 31, 2028
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06650163
