This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to
checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's
main objectives are to quantify the change in [18F]F AraG PET signal before and while on
CkIT therapy and to correlate this change in [18F]F AraG PET signal with radiographic
response.
To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment
[18F]F AraG PET/CT scans, and will be followed up for 12 months for assessment of
radiographic and clinical outcomes. This study is a single-site, open label, non
randomized, single arm pilot trial. Patients and care providers will not be blinded to
any part of the study.
Additional locations may be listed on ClinicalTrials.gov for NCT06107374.
See trial information on ClinicalTrials.gov for a list of participating sites.
Checkpoint inhibitor therapy has led to impressive clinical successes, providing
objective and durable responses in patients with advanced cancers that previously had few
treatment options. Unfortunately, immunotherapy works only in a relatively small fraction
of patients with solid tumors.
The current standard of care anatomic imaging adequately assessed treatment efficacy in
the pre-immunotherapy era, when tumor volume burden directly correlated with clinical
outcomes. However, anatomic imaging is found to be limited due to the cellular and
molecular nature of early responses to immunotherapy. PET imaging is a sensitive
technique that uses radiolabeled agents to visualize the distribution of specific
molecular targets in the body. Based on its ability to pinpoint molecular activity, PET
imaging agents that target key players of the immune response could offer a powerful
noninvasive tool for evaluating complex immunologic processes within the body.
[18F]F-AraG was developed as an agent for imaging activated T cells. [18F]F-AraG is an
18F-labeled analog of 9-b-D-Arabinofuranosylguanine a compound that has shown selective
accumulation in T cells and whose prodrug, nelarabine, is FDA-approved for the treatment
of patients with T cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma.
[18F]F-AraG is independent of the type of immunotherapy regimen being administered
adoptive cell therapy, checkpoint inhibitors, cancer vaccines or a combination of
immunotherapy and conventional medicines. In vivo, real-time imaging of activated T cells
in solid tumors before and at a timepoint during and after CkIT therapy can help
understand the effects of checkpoint blockade therapy. Additionally, in vivo whole-body
imaging of activated T cells can provide critical information about the effect of
immunomodulation in resulting in autoimmunity, and thus help predict adverse events of
immunotherapy.
To sum up, characterizing the immune system alterations in vivo, in real-time, and
non-invasively using PET imaging may enable us to predict better which patients will
benefit from which Checkpoint Inhibitor Therapy (CkIT) treatment regimen.
Lead OrganizationCellSight Technologies, Inc.
Principal InvestigatorMuhammad Furqan
