Evidence map›Paper›PMID 39762651›Full record

ReviewEMBO molecular medicine2025

CAR T-cell-associated secondary malignancies challenge current pharmacovigilance concepts.

Philipp Berg, Gabriele Ruppert-Seipp, Susanne Müller, Gabriele D Maurer, Jessica Hartmann, Udo Holtick, Christian J Buchholz, Markus B Funk

Abstract readReview
In one paragraph

Review in EMBO molecular medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. 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

8 authors.

Philipp BergSafety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.ORCID 0000-0003-0674-9031
Gabriele Ruppert-SeippSafety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.
Susanne MüllerSafety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.
Gabriele D MaurerSafety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany.ORCID 0000-0001-7329-6007
Jessica HartmannMolecular Biotechnology and Gene Therapy, Paul-Ehrlich-Institut, Langen, Germany.ORCID 0000-0001-9372-8954
Udo HoltickDepartment I of Internal Medicine, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany.
Christian J BuchholzMolecular Biotechnology and Gene Therapy, Paul-Ehrlich-Institut, Langen, Germany. Christian.Buchholz@pei.de.ORCID 0000-0002-9837-7345
Markus B FunkSafety of Biomedicines and Diagnostics, Paul-Ehrlich-Institut, Langen, Germany. Markus.Funk@pei.de.ORCID 0000-0001-8642-1276

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Suspected adverse reactions following chimeric antigen receptor T-cell (CAR T) treatment include more and more cases of secondary T-cell malignancies. The causality assessment of such suspected reactions challenges established evaluation practices due to (i) patient and product-specific risk factors and (ii) incomplete data available with post-marketing reports submitted to competent authorities. This is of particular relevance for gene therapy products that integrate into the host genome. We present a summary of case reports related to different CAR T products and the rationale for case causality assessment. In this context, possible pathophysiologic mechanisms and differences between CAR T products to be taken into account are discussed. The unparalleled complexity of the case follow-up and the multistep process of cancer development necessitates a case-by-case consideration. This highlights challenges in the pharmacovigilance of advanced therapy medicinal products and underlines the importance of testing for vector presence, integration location and gene expression profile for an informed case assessment of suspected secondary malignancies with the aim to obtain a better understanding of contributing factors.

Indexed as

Immunotherapy, AdoptiveNeoplasms, Second PrimaryPharmacovigilanceReceptors, Chimeric AntigenT-LymphocytesHumansReceptors, Chimeric AntigenAdverse ReactionGene TherapyInsertional MutagenesisMedicinal SafetyOncogenesis

Identifiers

PMID39762651
PMCPMC11822130

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.