Evidence map›Paper›PMID 30211249›Full record

ArticleMolecular therapy. Methods & clinical development2018

Screening Clinical Cell Products for Replication Competent Retrovirus: The National Gene Vector Biorepository Experience.

Kenneth Cornetta, Lisa Duffy, Steven A Feldman, Crystal L Mackall, Marco L Davila, Kevin J Curran, Richard P Junghans, Jean Yuh Tang, James N Kochenderfer, Roisin O'Cearbhaill and 9 more

Open access · goldAbstract read
In one paragraph

Article in Molecular therapy. Methods & clinical development, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 31 citations in OpenAlex.

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  15. Long-Term Follow-Up of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Article
  16. Review
  17. Article
  18. Article
  19. Mechanisms of resistance to CAR T cell therapy.Nature reviews. Clinical oncology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 1 country.

Kenneth CornettaDepartment of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
Lisa DuffyDepartment of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
Steven A FeldmanSurgery Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Crystal L MackallStanford Cancer Institute, Stanford University, Stanford, CA 94305, USA.
Marco L DavilaDepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Kevin J CurranDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY 10065, USA.
Richard P JunghansTufts Medical Center, Boston, MA 02111, USA.
Jean Yuh TangDepartment of Dermatology, Stanford University, Stanford, CA 94305, USA.
James N KochenderferExperimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD 20892, USA.
Roisin O'CearbhaillMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY 10021, USA.
Gary ArcherDepartment of Neurosurgery, Duke University Medical Center, Durham, NC 27710, USA.
Hans-Peter KiemFred Hutchinson Cancer Research Center and University of Washington School of Medicine, Seattle, WA 98109, USA.
Nirali N ShahPediatric Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Cindy DelbrookPediatric Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Rosie KaplanPediatric Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Renier J BrentjensDepartment of Medicine, Cellular Therapeutics Center, Center for Cell Engineering, and Molecular Pharmacology Program, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Isabelle RivièreCell Therapy and Cell Engineering Facility, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Michel SadelainCell Therapy and Cell Engineering Facility, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Steven A RosenbergSurgery Branch, National Cancer Institute, Bethesda, MD 20892, USA.
National Cancer Institute · USMemorial Sloan Kettering Cancer Center · USStanford University · USCornell University · USDuke Medical Center · USIndiana University – Purdue University Indianapolis · USIndiana University School of MedicineMoffitt Cancer Center · USTufts Medical Center · USUniversity of Washington · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeted Alpha-Particle Radiotheraphy of Brain Tumors with 211At-81C6 AntibodyP50CA190991 · NCI · DUKE UNIVERSITY · PI SAMPSON, JOHN H. · 2014 to 2023
$20.8M
Vanderbilt Clinical Oncology Research Career Development ProgramK12CA090625 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Debra L. Friedman, Paula Jill Hurley · 2001 to 2026
$16.9M
Biomarkers and Therapeutic Targets in Tumor Microenvironment and MetastasisZIABC011334 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KAPLAN, ROSANDRA NATASHA · 2010 to 2025
$10.8M
Personalized Immunotherapy of Patients with Ovarian CancerP01CA190174 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI IASONOS, ALEXIA E · 2015 to 2019
$10.5M
National Gene Vector Biorepository and Coordinating Center at Indiana UniversityP40HL116242 · NHLBI · INDIANA UNIVERSITY INDIANAPOLIS · PI CORNETTA, KENNETH · 2012 to 2017
$5.5M
Brain tumors with regulatory T-cells treated with EGFRvIII-specific T-cellsR01CA177476 · NCI · DUKE UNIVERSITY · PI SAMPSON, JOHN H. · 2013 to 2017
$2.3M
Hematopoietic Chemoprotection in Glioblastoma PatientsR01CA114218 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI KIEM, HANS-PETER · 2006 to 2011
$2.2M
NCI NIH HHS K12 CA090625NCI NIH HHS P01 CA190174NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA190991NCI NIH HHS R01 CA114218NCI NIH HHS R01 CA177476NHLBI NIH HHS P40 HL116242
6 · The paper itself

Abstract

Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, we reviewed 286 control (n = 4) and transduced cell products (n = 282) screened for RCR in the National Gene Vector Biorepository. The transduced cell samples were submitted from 14 clinical trials. All vector products were previously shown to be negative for RCR prior to use in cell transduction. After transduction, all 282 transduced cell products were negative for RCR. In addition, 241 of the clinical trial participants were also screened for RCR by analyzing peripheral blood at least 1 month after infusion, all of which were also negative for evidence of RCR infection. The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value.

Indexed as

lentivirusreplicating virusretrovirussafety testing

Identifiers

PMID30211249
PMCPMC6134358
OpenAlexW2886625553

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.