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

  • Kenneth CornettaEmail author
  • Sue Koop
  • Emily Nance
  • Kimberley House
  • Lisa Duffy
Part of the Methods in Molecular Biology book series (MIMB, volume 2086)


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.

Key words

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



This work was supported in part by a grant from the National Heart, Lung, and Blood Institutes 9P40HL116242 to K.C.


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  • Kenneth Cornetta
    • 1
    Email author
  • Sue Koop
    • 1
  • Emily Nance
    • 1
  • Kimberley House
    • 1
  • Lisa Duffy
    • 1
  1. 1.Department of Medical and Molecular GeneticsIndiana University School of MedicineIndianapolisUSA

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