June 24, 2025
Monitoring CAR-T Cell Therapy in Mantle Cell Lymphoma Using cfDNA and dPCR: Innovative Approaches
In this insightful webinar, Dr. Sascha Dierks from the University Medical Center Göttingen and Martin Becker from Stilla Technologies present their collaborative development of a novel digital PCR (dPCR) assay designed for monitoring CAR T-cell therapy in Mantle Cell Lymphoma (MCL). This innovative assay leverages the detection of the hallmark chromosomal translocation t(11;14) and quantification of CAR T-cell constructs in cell-free DNA, offering a highly sensitive, minimally invasive method for disease monitoring. The session also explores assay development, validation challenges, and potential clinical applications under evolving European diagnostics regulations.
Key Highlights:
- Dual Monitoring of Tumor and Therapy The presented 4-plex dPCR assay simultaneously tracks both the MCL-defining translocation (t(11;14)) and CAR T-cell constructs in a single reaction, allowing real-time assessment of therapeutic effectiveness and residual disease.
- Assay Sensitivity & Clinical Relevance Compared with standard diagnostic techniques (FISH, FACS), the assay shows high correlation and superior sensitivity, capable of detecting minimal residual disease well before clinical relapse, potentially months in advance.
- Future Clinical Translation & Challenges The assay shows strong proof-of-concept results, but translation into clinical diagnostics will require meeting IVDR regulatory requirements, larger patient studies, and standardization—underscoring both its promise and pathway to routine clinical use.