NCT06650163 Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
| NCT ID | NCT06650163 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-12-05 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Robert M Prins
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06650163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06650163 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06650163 currently recruiting?
Yes, NCT06650163 is actively recruiting participants. Contact the research team at sichenli@mednet.ucla.edu for enrollment information.
Where is the NCT06650163 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06650163 clinical trial?
NCT06650163 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Robert M Prins at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 20 participants.