Replication-Competent Lentivirus Analysis of Vector-Transduced T Cell Products Used in Cancer Immunotherapy Clinical Trials

Kenneth Cornetta, Sue Koop, Emily Nance, Kimberley House, Lisa Duffy

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Lentiviral vectors are being used in a growing number of clinical applications, including T cell immunotherapy for cancer. As this new technology moves forward, a safety concern is the inadvertent recombination and subsequent development of a replication-competent lentivirus (RCL) during the manufacture of the vector material. To assess this risk, regulators have required screening of T cell products infused into patients for RCL. Since vector particles have many of the proteins and nucleotide sequences found in RCL, a biologic assay has proven the most sensitive method for RCL detection. As regulators have required screening of up to 108 cells per T cell product, this method described a procedure for assessing RCL contamination of large-volume T cell products.

Original languageEnglish (US)
Title of host publicationMethods in Molecular Biology
PublisherHumana Press Inc.
Pages181-194
Number of pages14
DOIs
StatePublished - Jan 1 2020

Publication series

NameMethods in Molecular Biology
Volume2086
ISSN (Print)1064-3745
ISSN (Electronic)1940-6029

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Keywords

  • Lentiviral vectors, T cell immunotherapy, Replication-competent lentivirus, Clinical trials, CAR-T cells

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics

Cite this

Cornetta, K., Koop, S., Nance, E., House, K., & Duffy, L. (2020). Replication-Competent Lentivirus Analysis of Vector-Transduced T Cell Products Used in Cancer Immunotherapy Clinical Trials. In Methods in Molecular Biology (pp. 181-194). (Methods in Molecular Biology; Vol. 2086). Humana Press Inc.. https://doi.org/10.1007/978-1-0716-0146-4_13