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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Advanced Magnetic Resonance Imaging
  Undergo advanced MRI
• Процедура Brain Surgery
  Undergo brain surgery
• Другое Electronic Health Record Review
  Ancillary studies
• Процедура Immuno-Positron Emission Tomography Scan
  Undergo immuno-PET
• Процедура Magnetic Resonance Imaging
  Undergo MRI
• Процедура Stereotactic Biopsy
  Undergo stereotactic image-guided biopsy
• Диагностический тест Zirconium Zr 89 Crefmirlimab Berdoxam
  Undergo Zirconium Zr 89 Crefmirlimab Berdoxam PET

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT06650163 · 24-000877 · NCI-2024-08388 · 24-000877 · P30CA016042 · P50CA211015 · R01CA267726

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗