A Novel Antigen-Specific Automated and Standardized Functional Assay for Car-T Cell Potency and Persistence Assessment During Car-T Cell Therapy Treatment

The therapeutic efficacy of chimeric antigen receptor T-cell (CAR-T) therapy depends on both the intrinsic potency of the infused product and the functional persistence of CAR-T cells in vivo. Current lot-release assays (e.g., mitogen-based stimulation) and post-infusion monitoring tools (e.g., flow cytometry, qPCR) are functionally agnostic and lack standardized correlation with clinical outcomes. This gap highlights the need for a unified, function-based platform linking product quality to patient response.

We developed a standardized immune functional assay on VIDAS^® 3, applied in three contexts:

• As a potency assay for lot-release testing of pre-infusion CAR-T products
• As a general T-cell function monitoring tool to assess T-cell function in patient blood
• As a post-infusion monitoring tool to assess CAR-T functional persistence in patient blood

This poster explores how VIDAS^® 3 is a fast, reliable, and standardized solution for monitoring patients treated with CAR‑T cells. We validated a CAR‑T potency assay within 4 hours and demonstrated:

• The relevance of monitoring CAR‑T cell persistence post‑infusion
• The benefit of assessing the global functionality of T cells
• The slight impact of cryopreservation