Evidence map›Paper›PMID 41445185›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2026

Impact of vector copy number on critical quality attributes of retrovirally engineered T cells.

Scott M Norberg, Rupali Gund, Ekaterina Doubrovina, Stacey L Doran, Tatyana Fuksenko, Hui Liu, Jinxia Ma, Zulmarie Franco, Christian S Hinrichs

Abstract read
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

9 authors.

Scott M NorbergCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. Electronic address: scott.norberg@nih.gov.
Rupali GundDuncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ 08901, USA.
Ekaterina DoubrovinaDuncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ 08901, USA.
Stacey L DoranCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.
Tatyana FuksenkoCenter for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Hui LiuCenter for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Jinxia MaCenter for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Zulmarie FrancoCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA; Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Christian S HinrichsDuncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ 08901, USA. Electronic address: ch977@cijn.rutgers.edu.

Funding

TRANSCRIPTIONAL PROFILINGP30CA072720 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Tracie Saunders · 1997 to 2026
$94.5M
Intramural NIH HHS Z99 CA999999NCI NIH HHS P30 CA072720
6 · The paper itself

Abstract

Genetically engineered T cell therapies are approved by the FDA for the treatment of various cancers. The cell products in these treatments are manufactured using retroviral vectors to insert an antigen-targeting receptor into the T cell genome. Limited data exist on how vector copy number (VCN) per transduced cell impacts critical quality attributes (CQAs) of retrovirally engineered T cell products. We investigated the effect of VCN on the purity and potency of E7 T cells, a T cell receptor (TCR)-engineered cell product that has shown safety and clinical activity in human papillomavirus (HPV)-associated cancers. An increased VCN correlated with enhanced functional characteristics, including transduction efficiency, tumor recognition as measured by IFN-γ production, and cytotoxic activity in real-time killing assays. We then analyzed archived retention vials from E7 T cell products from a clinical trial prior to FDA guidance on VCN limits. The median VCN was >5, and there were no cases of insertional oncogenesis. These findings demonstrate a positive correlation between VCN and improved cell product purity and potency and contribute to existing clinical data showing a low risk of insertional oncogenesis in retrovirally engineered T cell therapies.

Indexed as

Gene DosageGenetic VectorsRetroviridaeT-LymphocytesHumansImmunotherapy, AdoptiveReceptors, Antigen, T-CellTransduction, GeneticReceptors, Antigen, T-Celladoptive T cell therapyCAR T cell therapycell manufacturingchimeric antigen receptor T cell therapysecondary malignancyT cell receptor-T cell therapyTCR-T cell therapyVCNvector copy number

Identifiers

PMID41445185
PMCPMC12817206

What OpenQuestion holds

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Registered trials

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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.