This clinical trial test whether [18F]F-AraG positron emission tomography (PET)/computed tomograpy (CT) works in determining immunological response to chimeric antigen receptor (CAR)-T cell therapy in patients with aggressive B-cell lymphoma. [18F]F-AraG is an imaging agent that may help monitor immune system response to CAR T cell therapy with axicabtagene ciloleucel (Yescarta) as part of anticancer therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05096234.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Explore the relationship of change in fluorine F 18 Ara-G ([18F]F-AraG) PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.
EXPLORATORY OBJECTIVES:
I. Explore the relationship of change in [18F]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as complete response (CR) + partial response (PR) + stable disease (SD) >= 3 months) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.
II. Correlate the change in [18F]F-AraG PET signal following CAR T cell treatment with maximum grade of cytokine release syndrome (CRS) and neurotoxicity experienced.
OUTLINE:
Patients receive [18F]F-AraG intravenously (IV) and then undergo PET/CT scan at baseline and 4 days after cell infusion.
After completion of study, patients are followed up at 4 weeks.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorDavid B. Miklos
