ESGCT 2024 -- Transduced cell therapies, e.g., CAR-T cells, offer a powerful therapeutic strategy for treatment of various cancers and auto-immune diseases. CAR-T and analogous therapies are often transduced using lentiviral vectors to integrate the chimeric antigen receptor (CAR) construct into the cell line. The use of lentiviral vectors introduces the risk of patient exposure, with a particular concern regarding replication competent lentivirus (RCL). In addition to RCL testing during cell product release, there is a necessity to establish the absence of RCL over the course of clinical studies assessing lentiviral-transduced cell therapy products. The current FDA recommendation for clinical monitoring is for testing of blood/PBMCs for the absence of RCL before dosing and, periodically over the course of at least the first year following dosing. In addition to target-specific transduced cell therapy vector copy number (VCN) method development and validation, Labcorp supports RCL testing for clinical samples with a validated VSV-G envelope protein targeting qPCR method. Recent further validation work has refined the previously manual whole blood extraction method to an automated process using half the sample input and aligning with extractions supporting VCN analyses.

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