PAC19 VCN ddPCR test
Case study
The PAC19 VCN digital droplet (dd)PCR test was validated by ICON to detect and monitor CAR-T (chimeric antigen receptor) cell expansion and persistence in patients receiving anti-CD19 CAR-T therapies.
Challenge
Chimeric antigen receptor T (CAR-T) cell therapy requires a retrovirus or lentivirus to introduce the chimeric antigen. Several clinical trials are focusing on CD19-specific CAR-T therapies to treat B-cell malignancies. CAR-T therapies require testing at different stages and intervals, to perform baseline assessment on clinical drug products, pharmacokinetics (PK)-like monitoring and long-term follow-up on patients receiving the CAR-T. The need for the development of highly sensitive and accurate assays for measuring CAR-T products is increasing, as more biotechnology and pharmaceutical companies are developing immunotherapies which require molecular testing and monitoring by regulatory agencies.
Solution
ICON took advantage of the similarities between anti-CD19 CAR constructs and created a pan anti-CD19 (PAC19) VCN ddPCR test. The PAC19 VCN ddPCR test was developed to detect and quantify the anti-CD19 CAR transgene, comprised of a CD19-specific, extracellular, single chain variable fragment (scFv) derived from the murine FMC63 monoclonal antibody, linked to the signaling domain from CD28 or 4-1BB and the zeta (ζ) domain of CD3 (CD3ζ).
Outcome
The PAC19 VCN ddPCR test validated by ICON Specialty Laboratories can be offered to any sponsor investing in clinical trials targeting anti-CD19 CAR-T. The assay can be used to detect and monitor CAR-T cell expansion and persistence.
ICON Specialty Laboratories partners with clients to design, verify and validate clinical trial assays (CTA) for patient selection, therapeutic efficacy, and monitoring. We are at the forefront of precision medicine diagnostic technology and our expertise ensures reliable and accurate results for pivotal clinical end points. When you partner with ICON you have access to:
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Scientific expertise for planning and risk mitigation, starting in pre-clinical/phase 1
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RCL, RCR & VCN safety testing via ddPCR and qPCR methods
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Advanced technology platforms such as NGS, droplet digital PCR, and IHC to support emerging biomarkers
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Novel approaches that leverage advanced genomic platforms such as targeted RNA sequencing, tumour mutation load, liquid biopsy, and tumour infiltrating lymphocytes
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Biomarker assay specialists to design a durable, fit-for-purpose test
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Platform partnerships with key IVD and application suppliers