Evidence map›Paper›PMID 41345813›Full record

ReviewDrug safety2026

Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus.

Anna Fettiplace, Arie Regev, Alexandre Kiazand, Ulrike Heinzel-Pleines, Mahnoush Bahjat, Anju Garg, Luciana Kikuchi, Hewei Li, Ali Hamidi, David H Alpers and 4 more

Abstract readConsensus StatementReview
In one paragraph

Review in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

14 authors.

Anna FettiplaceAstraZeneca, Cambridge, UK. anna@fettiplaceconsulting.com.ORCID http://orcid.org/0009-0008-1875-2928
Arie RegevEli Lilly and Company, Indianapolis, USA.ORCID http://orcid.org/0000-0001-6570-7769
Alexandre KiazandAstraZeneca, Cambridge, USA.ORCID http://orcid.org/0000-0002-3749-1291
Ulrike Heinzel-PleinesBayer Pharmaceuticals, Leverkusen, Germany.ORCID http://orcid.org/0009-0005-7183-1973
Mahnoush BahjatImmunology Safety, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK.ORCID http://orcid.org/0000-0002-0738-1905
Anju GargSanofi, Patient Safety and Pharmacovigilance, Morristown, NJ, USA.
Luciana KikuchiBayer, SA, São Paulo, Brazil.ORCID http://orcid.org/0009-0004-3247-4232
Hewei LiGlobal Medical Safety, Johnson & Johnson, New Brunswick, NJ, USA.
Ali HamidiAmgen, Thousand Oaks, USA.ORCID http://orcid.org/0009-0008-9551-9476
David H AlpersDepartment of Medicine, Washington University School of Medicine, St Louis, MO, USA.ORCID http://orcid.org/0000-0002-0539-1042
Hans TillmannDivision Gastroenterology, Hepatology and Nutrition, East Carolina University, Greenville, NC, USA.ORCID http://orcid.org/0000-0003-1401-2208
Dominique LarreyLiver Unit, Saint Eloi Hospital, Montpellier School of Medicine, Montpellier, France.ORCID http://orcid.org/0000-0002-0892-3489
Adrian M Di BisceglieSaint Louis University, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-6075-9305
James H LewisGeorgetown University Hospital, Washington, DC, USA.ORCID http://orcid.org/0000-0002-6686-3744

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chimeric antigen receptor T-cell (CAR-T) therapy is a rapidly expanding key therapeutic category, originally pioneered for haematological malignancies, now being developed into treatments for solid tumours and non-malignant immune-mediated conditions. Chimeric antigen receptor T-cell therapies have some relatively unique toxicities which can affect the liver, in addition to potential drug-induced liver injury and hepatitis B virus reactivation. This manuscript was developed by the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Drug-induced Liver Injury (DILI) Initiative that consists of members from 17 pharmaceutical companies, in collaboration with academic and regulatory DILI experts. The aim was to produce a comprehensive guide to summarise the hepatic effects of CAR-T, and to propose an approach to the investigation of liver test changes. The clinical characteristics of liver test changes in association with cytokine release syndrome and immune-effector cell haemophagocytic lymphohistiocytosis are described, to enable these anticipated hepatic effects to be distinguished from other causes of abnormal liver tests. The frequency and timing of many primary and secondary liver conditions that may present after CAR-T therapy are described. This review provides the first detailed description of both anticipated and unpredictable hepatic effects of CAR-T cell therapies and is intended to assist in the future characterisation of hepatic effects of CAR-T therapies as programmes move into areas with a different benefit/risk profile, such as autoimmune or other non-oncology indications.

Indexed as

Chemical and Drug Induced Liver InjuryImmunotherapy, AdoptiveReceptors, Chimeric AntigenHumansReceptors, Chimeric Antigen

Identifiers

PMID41345813
PMCPMC13161348

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.