RECRUITING

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

Conditions

Glioma Malignant Brain Neoplasm Meningioma Metastatic Malignant Neoplasm in the Brain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biologic Validation of Zr-89 Crefmirlimab Berdoxam CD8+ Minibody ImmunoPET in Human Brain Tumors

Quick Facts

Study Start:2024-12-05

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06650163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sichen Li

CONTACT

310-592-9091

sichenli@mednet.ucla.edu

Principal Investigator

Robert M Prins

PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

Robert M Prins, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-05

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-12-05

Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

Glioma
Malignant Brain Neoplasm
Meningioma
Metastatic Malignant Neoplasm in the Brain