This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04409314.
PRIMARY OBJECTIVE:
I. To evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (R/R) malignancies before treatment with chimeric antigen receptor (CAR) T-cell therapy.
SECONDARY OBJECTIVE:
I. To evaluate the association between intratumoral hypoxia and clinical responses to CAR T-cell therapy.
EXPLORATORY OBJECTIVES:
I. To correlate intratumoral hypoxia with markers of CAR T-cell activity and toxicity.
2. To correlate pre-therapy fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) uptake with pre-therapy 18Ffluorodeoxyglucose (FDG) positron emission tomography (PET) uptake (if available).
OUTLINE:
Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes.
After completion of study, patients are followed up for up to 6 months after CAR T-cell therapy.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorCharalambos Andreadis
