Methods for assessing the suitability of transduced T cells for administration

摘要

The invention relates to of analyzing vector supernatants useful for transducing T cells destined for administration to a human subject. The invention also related to methods of analyzing transduced T cells destined for administration to a human subject.

主权项

1. A method of analyzing a composition comprising a genetically modified T cell to detect a contaminant, the method comprises:
preparing the composition comprising the genetically modified T cell, wherein the genetically modified T cell comprises a nucleic acid encoding a chimeric antigen receptor (CAR) comprising an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a signaling domain; and analyzing the composition for at least one contaminant selected from the group consisting of a replication competent lentivirus (RCL), p24, a nucleic acid and/or protein derived from a plasmid used to package a lentivirus plasmid, vesicular stomatitis virus G-protein (VSV-G) nucleic acid and/or protein, and human immunodeficiency virus (HIV) gag.