Researchers are working to accelerate the clinical adoption of novel allogeneic cell therapies to improve cancer care and treatment, according to a new report from the College of American Pathologists (CAP).
Background
Allogeneic cell therapy—which uses cells from a healthy donor rather than a patient's own cells—provides an off-the-shelf therapeutic approach for greater adoption of cellular therapy. However, its widespread implementation faces challenges such as immune rejection, treatment toxicity, and the complexity of monitoring therapeutic effects. Currently, there is a lack of widely established diagnostic tests and validated biomarkers for allogeneic cell therapies.
Bringing Allogeneic Cell Therapies to Cancer Care
In the report, the researchers detailed how diagnostic laboratories can play a pivotal role in advancing the safety and efficacy of emerging allogeneic cell therapies. They emphasized that pathologists are uniquely positioned to support the clinical integration of allogeneic cellular therapies.
“While diagnostic laboratories currently lack specific biomarkers or standardized tests for these therapies, we can optimize how existing tools are used and develop innovative approaches to improve monitoring and safety,” noted co–report author Matthew Anderson, MD, PhD, A(ACHI), FCAP, a member of the CAP Personalized Health Care Committee.
The researchers highlighted three areas in which pathologists may be driving innovation, including:
- Enhancing safety through advanced monitoring: Pathologists are already utilizing a variety of laboratory tests and markers such as cytokines and inflammatory markers to detect and prevent potentially life-threatening complications like cytokine-release syndrome. Additionally, laboratory methods are continuously adapted and refined to identify high-risk patients prior to treatment, enabling preventive interventions and personalized care protocols.
- Addressing immune rejection and compatibility challenges: Immune rejection remains a critical barrier to the success of allogeneic cellular therapy. Laboratory experts are enhancing and repurposing next-generation compatibility testing and immune-profiling techniques to reduce the risk of graft-vs-host disease and prevent allosensitization. Advances in human leukocyte antigen matching, donor-specific antibody detection, and next-generation immune monitoring could enable physicians to better assess rejection risks and refine treatment strategies on a patient-by-patient basis.
- Innovating to ensure long-term treatment success: Pathology laboratories are exploring innovative methods to track the persistence, functionality, and efficacy of allogeneic cell therapies over time. By adapting genomic surveillance, single-cell analysis, and artificial intelligence–driven monitoring approaches, pathologists are developing more effective tools to predict treatment durability, assess therapeutic responses, and refine posttreatment care strategies.
Conclusions
By leveraging existing diagnostic approaches, refining current testing methodologies, and fostering collaboration, pathologists can help bridge the gap between research and real-world clinical applications.
As novel therapeutics move toward broader clinical adoption, the researchers indicated that pathologists could play a crucial role in establishing the testing infrastructure and quality standards necessary for safe and effective implementation. While no single biomarker or standardized test currently exists for these therapies, pathologists are at the forefront of efforts to optimize and innovate across existing diagnostic frameworks. The CAP report emphasized that collaboration among laboratory medicine experts, physicians, and regulatory agencies may be essential in translating these therapies from clinical trials to standard care.
“Pathologists aren't merely supporting allogeneic cellular therapy development—they're actively shaping how it will be integrated into clinical practice,” underscored co–report author Fabienne Lucas, MD, PhD, FCAP, a member of the CAP Personalized Health Care Committee. “Our diagnostic expertise represents the cornerstone of a safer, more accessible cellular therapy ecosystem that will fundamentally transform treatment paradigms,” she concluded.
To view the full report, visit cap.org.
