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Replication competent retrovirus testing (RCR) in the National Gene Vector Biorepository: No evidence of RCR in 1,595 post-treatment peripheral blood samples obtained from 60 clinical trials.
Cornetta, Kenneth; Yao, Jing; House, Kimberley; Duffy, Lisa; Adusumilli, Prasad S; Beyer, Rachel; Booth, Claire; Brenner, Malcolm; Curran, Kevin; Grilley, Bambi; Heslop, Helen; Hinrichs, Christian S; Kaplan, Rosandra N; Kiem, Hans-Peter; Kochenderfer, James; Kohn, Donald B; Mailankody, Sham; Norberg, Scott M; O'Cearbhaill, Roisin E; Pappas, Jennifer; Park, Jae; Ramos, Carlos; Ribas, Antonio; Rivière, Isabelle; Rosenberg, Steven A; Sauter, Craig; Shah, Nirali N; Slovin, Susan F; Thrasher, Adrian; Williams, David A; Lin, Tsai-Yu.
Afiliação
  • Cornetta K; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA; Brown Center for Immunotherapy, Indiana University School of Medicine, Indianapolis, IN, USA. Electronic address: kcornett@iu.edu.
  • Yao J; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
  • House K; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
  • Duffy L; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
  • Adusumilli PS; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Beyer R; Surgery Branch, NCI, Bethesda, MD 20892, USA.
  • Booth C; Molecular and Cellular Immunology, UCL Great Ormond Street Institute of Child Health, London, UK.
  • Brenner M; Center for Cell and Gene Therapy Baylor College of Medicine, Houston TX, USA.
  • Curran K; Memorial Sloan Kettering Cancer Center, Department of Pediatrics, New York, NY, USA; Weill Cornell Medical College, Department of Pediatrics, New York, NY, USA.
  • Grilley B; Center for Cell and Gene Therapy Baylor College of Medicine, Houston TX, USA.
  • Heslop H; Center for Cell and Gene Therapy Baylor College of Medicine, Houston TX, USA.
  • Hinrichs CS; Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence, New Brunswick, NJ 08901, USA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ 08901, USA.
  • Kaplan RN; Pediatric Oncology Branch, Center for Cancer Research, NCI, Bethesda, MD 20892, USA.
  • Kiem HP; Fred Hutchison Cancer Center and University of Washington, Seattle, WA, USA.
  • Kochenderfer J; Center for Cancer Research, Surgery Branch, NCI, NIH, Bethesda MD, USA.
  • Kohn DB; Departments of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology) and Molecular and Medical Pharmacology, University of California, Los Angeles, Los Angeles, CA, USA.
  • Mailankody S; Myeloma and Cellular Therapy Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Norberg SM; NCI, Center for Immuno-Oncology, Bethesda, MD 20892, USA.
  • O'Cearbhaill RE; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Pappas J; Surgery Branch, NCI, Bethesda, MD 20892, USA.
  • Park J; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Ramos C; Center for Cell and Gene Therapy Baylor College of Medicine, Houston TX, USA.
  • Ribas A; Jonsson Comprehensive Cancer Center at the University of California Los Angeles (UCLA), Los Angeles, CA 90095, USA.
  • Rivière I; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Rosenberg SA; Surgery Branch, NCI, Bethesda, MD 20892, USA.
  • Sauter C; Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.
  • Shah NN; Pediatric Oncology Branch, Center for Cancer Research, NCI, Bethesda, MD 20892, USA.
  • Slovin SF; Genitourinary Oncology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Thrasher A; Molecular and Cellular Immunology, UCL Great Ormond Street Institute of Child Health, London, UK.
  • Williams DA; Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
  • Lin TY; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA; Brown Center for Immunotherapy, Indiana University School of Medicine, Indianapolis, IN, USA.
Mol Ther ; 31(3): 801-809, 2023 03 01.
Article em En | MEDLINE | ID: mdl-36518078
ABSTRACT
The clinical impact of any therapy requires the product be safe and effective. Gammaretroviral vectors pose several unique risks, including inadvertent exposure to replication competent retrovirus (RCR) that can arise during vector manufacture. The US FDA has required patient monitoring for RCR, and the National Gene Vector Biorepository is an NIH resource that has assisted eligible investigators in meeting this requirement. To date, we have found no evidence of RCR in 338 pre-treatment and 1,595 post-treatment blood samples from 737 patients associated with 60 clinical trials. Most samples (75%) were obtained within 1 year of treatment, and samples as far out as 9 years after treatment were analyzed. The majority of trials (93%) were cancer immunotherapy, and 90% of the trials used vector products produced with the PG13 packaging cell line. The data presented here provide further evidence that current manufacturing methods generate RCR-free products and support the overall safety profile of retroviral gene therapy.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Retroviridae / Replicação Viral Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Retroviridae / Replicação Viral Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article