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Practical considerations for clinical translation of PET imaging of adoptive cell therapies
Alessia Volpe1, Jonathan Pham2, Mark A Sellmyer3,4
1Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Abstract:
Research and development programs for adoptive cell therapies continue to expand, but few products make it to late-phase clinical trials, and even fewer receive FDA approval. Despite undergoing extensive validation before entering the trial phase, variable results may be observed in patients due to inherent differences between preclinical models and human subjects as well as heterogeneity between tumors. Moreover, the current clinical evaluation of cell therapies, including CAR-T cells, relies on limited or inconclusive approaches - usually blood sampling or tissue biopsies - lacking spatial and temporal information about their fate in the human body. Here we offer our perspective on how the application of PET imaging to track cell therapies in clinical studies could address these shortcomings and enhance our understanding of cell therapy biodistribution, patients and trial-level therapeutic success or failure, and safety considerations. We further address key challenges, from probe development to methodological, technical, and regulatory, and financial hurdles for integrating PET imaging of cell therapies into clinical studies.
Insights
Positron emission tomography (PET) imaging can track adoptive cell therapies, improving understanding of their fate in patients. This approach addresses limitations in current methods, enhancing clinical trial success and safety assessments.
Area of Science:
- Cellular Therapy
- Medical Imaging
Background:
- Adoptive cell therapies show promise but face challenges in clinical translation.
- Current methods for evaluating cell therapy efficacy lack spatial and temporal resolution.
Purpose of the Study:
- To propose Positron Emission Tomography (PET) imaging as a tool for tracking cell therapies in clinical studies.
- To enhance understanding of cell therapy biodistribution, efficacy, and safety.
Main Methods:
- Review of current limitations in cell therapy evaluation.
- Perspective on the application of PET imaging for cell therapy tracking.
- Discussion of challenges in integrating PET imaging into clinical studies.
Main Results:
- PET imaging offers a solution to limited spatial and temporal data from current methods.
- PET can provide insights into cell therapy biodistribution and patient-specific responses.
- Improved monitoring can aid in assessing therapeutic success and safety.
Conclusions:
- PET imaging holds significant potential to advance the clinical evaluation of cell therapies.
- Overcoming technical, regulatory, and financial challenges is crucial for PET integration.
- PET imaging can optimize cell therapy development and patient care.
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