GliomaPhase 1NCT06650163
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
A Phase 1 study testing Advanced Magnetic Resonance Imaging, Brain Surgery and Electronic Health Record Review in people with Glioma and Malignant Brain Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant Brain Neoplasm, Meningioma
- What is being tested?
- Advanced Magnetic Resonance Imaging, Brain Surgery and Electronic Health Record Review
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Sichen Li, 310-794-5663, sichenli@mednet.ucla.edu
Robert M. Prins, PhD
About this study
Official title: Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Advanced Magnetic Resonance Imaging, Brain Surgery, Electronic Health Record Review, Immuno-Positron Emission Tomography Scan, Magnetic Resonance Imaging
- Medical subject headings
- Glioma, Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Magnetic Resonance ImagingProcedure or surgery
Also called AMRI
Undergo advanced MRI
Brain SurgeryProcedure or surgery
Undergo brain surgery
Electronic Health Record ReviewOther
Ancillary studies
Immuno-Positron Emission Tomography ScanProcedure or surgery
Also called Immuno-PET Scan
Undergo immuno-PET
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Stereotactic BiopsyProcedure or surgery
Undergo stereotactic image-guided biopsy
Zirconium Zr 89 Crefmirlimab BerdoxamDiagnostic test
Also called 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2C
Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start5 Dec 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert M Prins, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650163
- Sponsor's protocol ID
- 24-000877
- Other IDs
- NCI-2024-08388, 24-000877, P30CA016042, P50CA211015, R01CA267726
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors
- ClinicalTrials.gov ID
- NCT06650163
- Acronym / sponsor ID
- 24-000877
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) | Experimental | 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 BerdoxamPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Magnetic Resonance ImagingAlso: AMRIUndergo advanced MRI | Procedure or surgery | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Brain SurgeryUndergo brain surgery | Procedure or surgery | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Immuno-Positron Emission Tomography ScanAlso: Immuno-PET ScanUndergo immuno-PET | Procedure or surgery | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Stereotactic BiopsyUndergo stereotactic image-guided biopsy | Procedure or surgery | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
| Zirconium Zr 89 Crefmirlimab BerdoxamAlso: 89Zr-Crefmirlimab Berdoxam, 89Zr-Desferrioxamine-IAB22M2C, 89Zr-Df-Crefmirlimab, 89Zr-Df-IAB22M2CUndergo Zirconium Zr 89 Crefmirlimab Berdoxam PET | Diagnostic test | Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET) |
Primary outcome
Incidence of adverse events
Time frame: Up to 1 month
Analyses will be examined graphically and summarized by descriptive statistics. Data transformation may be applied to quantitative variables prior to analyses if deemed necessary.
Zirconium (Zr)-89 crefmirlimab berdoxam uptake
Time frame: Up to 24 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert M Prins principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Advanced Magnetic Resonance Imaging, Brain Surgery and Electronic Health Record Review in people with Glioma and Malignant Brain Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sichen Li (310-592-9091, sichenli@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.