Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650163
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8 Minibody ImmunoPET in Human Brain Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None