18F-F-AraG PET Imaging for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByDavid Miklos, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.

Eligibility Criteria

Adults over 18 with aggressive B-cell non-Hodgkin's lymphoma eligible for CAR T cell therapy can join. They must have a type of tumor visible on PET scans, not located in sensitive areas like the head or abdomen, and be able to undergo a biopsy. Pregnant women and those with significant GI tract involvement by cancer cannot participate.

Inclusion Criteria

My diagnosis is aggressive B cell non-Hodgkin lymphoma.

I am scheduled for CAR T cell therapy with axicabtagene ciloleucel.

I am 18 years old or older.

Exclusion Criteria

My PET scan shows significant GI tract disease.

I am not pregnant or breastfeeding.

Participant Groups

The trial is testing how well [18F]F-AraG PET imaging works in evaluating the body's immune response to CAR T cell therapy in patients with aggressive B-cell lymphoma. It aims to see if this imaging method can effectively monitor treatment progress.

1Treatment groups

Experimental Treatment

Group I: [18F]F-AraG PETExperimental Treatment1 Intervention

Subjects will undergo PET imaging at the following time points: * Baseline, prior to lymphodepleting chemotherapy: \[18F\]F-AraGPET/CT, followed the next day by FDG-PET/CT * At peak CAR expansion: Day 4 (± 2 days) post-CAR infusion: \[18F\]F-AraG PET * At Day +28 (± 4 days) post-CAR infusion: FDG-PET/CT Subjects will have a paired biopsy after each imaging time point, if possible. Subjects will be followed for safety of \[18F\]F-AraG for 30 days after last dose