Evidence map›Paper›PMID 36518079›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2023

Detection of chromosomal alteration after infusion of gene-edited allogeneic CAR T cells.

Barbra J Sasu, Gregory J Opiteck, Suhasni Gopalakrishnan, Vivek Kaimal, Tom Furmanak, David Huang, Angshumala Goswami, Ying He, Jiamin Chen, Anh Nguyen and 13 more

Open access · hybridAbstract read
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2023. 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
2.4field-weighted citation impact, top 9% 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, 23 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Clinical translation of epigenome editing technologies.Current opinion in biomedical engineering · 2026
    Article
  5. Review
  6. Review
  7. Clinical development of allogeneic chimeric antigen receptor αβ-T cells.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
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  15. Article
  16. Article
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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

23 authors at 2 institutions in 1 country.

Barbra J SasuAllogene Therapeutics, South San Francisco, CA 94080, USA.
Gregory J OpiteckAllogene Therapeutics, South San Francisco, CA 94080, USA.
Suhasni GopalakrishnanAllogene Therapeutics, South San Francisco, CA 94080, USA.
Vivek KaimalAllogene Therapeutics, South San Francisco, CA 94080, USA.
Tom FurmanakAllogene Therapeutics, South San Francisco, CA 94080, USA.
David HuangAllogene Therapeutics, South San Francisco, CA 94080, USA.
Angshumala GoswamiAllogene Therapeutics, South San Francisco, CA 94080, USA.
Ying HeAllogene Therapeutics, South San Francisco, CA 94080, USA.
Jiamin ChenAllogene Therapeutics, South San Francisco, CA 94080, USA.
Anh NguyenAllogene Therapeutics, South San Francisco, CA 94080, USA.
Arun BalakumaranAllogene Therapeutics, South San Francisco, CA 94080, USA.
Nirav N ShahDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
Mehdi HamadaniDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
Kathleen M BoneDepartment of Pathology, Medical College of Wisconsin, Milwaukee, WI 53226, USA.
Sacha PrashadAllogene Therapeutics, South San Francisco, CA 94080, USA.
Michael A BowenAllogene Therapeutics, South San Francisco, CA 94080, USA.
Thomas PertelAllogene Therapeutics, South San Francisco, CA 94080, USA.
Heather D EmbreeAllogene Therapeutics, South San Francisco, CA 94080, USA.
Shalini G GidwaniAllogene Therapeutics, South San Francisco, CA 94080, USA.
David ChangAllogene Therapeutics, South San Francisco, CA 94080, USA.
Alison MooreAllogene Therapeutics, South San Francisco, CA 94080, USA.
Mark LeonardAllogene Therapeutics, South San Francisco, CA 94080, USA.
Rafael G AmadoAllogene Therapeutics, South San Francisco, CA 94080, USA. Electronic address: rafael.amado@allogene.com.
Allogene Therapeutics (United States) · USMedical College of Wisconsin · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A chromosome 14 inversion was found in a patient who developed bone marrow aplasia following treatment with allogeneic chimeric antigen receptor (CAR) Tcells containing gene edits made with transcription activator-like effector nucleases (TALEN). TALEN editing sites were not involved at either breakpoint. Recombination signal sequences (RSSs) were found suggesting recombination-activating gene (RAG)-mediated activity. The inversion represented a dominant clone detected in the context of decreasing absolute CAR Tcell and overall lymphocyte counts. The inversion was not associated with clinical consequences and wasnot detected in the drug product administered to this patient or in any drug product used in this or other trials using the same manufacturing processes. Neither was the inversion detected in this patient at earlier time points or in any other patient enrolled in this or other trials treated with this or other product lots. This case illustrates that spontaneous, possibly RAG-mediated, recombination events unrelated to gene editing can occur in adoptive cell therapy studies, emphasizes the need for ruling out off-target gene editing sites, and illustrates that other processes, such as spontaneous V(D)J recombination, can lead to chromosomal alterations in infused cells independent of gene editing.

Indexed as

Hematopoietic Stem Cell TransplantationReceptors, Chimeric AntigenGene EditingHumansImmunotherapy, AdoptiveT-LymphocytesTranscription Activator-Like Effector NucleasesReceptors, Chimeric AntigenTranscription Activator-Like Effector Nucleasescancer immunotherapyCAR T cell therapygene editingrecombination-activating gene-mediated activitysyngeneic cell therapyTALEN gene editing

Identifiers

PMID36518079
PMCPMC10014221
OpenAlexW4311301708

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.