Evidence mapPaperPMID 41869330Full record

ArticleFrontiers in immunology2026

Real-world safety profile of T-cell engagers: evidence from multi-database analysis with CAR-T comparisons.

Jinman Zhong, Chang Chen, Yunman Xu, Yueping He, Jingwen Luo, Changxiu Zhang, Jiewen Tan, Dan Xiong

Abstract readComparative Study
In one paragraph

Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Jinman ZhongDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Chang ChenDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Yunman XuDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Yueping HeDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Jingwen LuoDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Changxiu ZhangDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Jiewen TanDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.
Dan XiongDepartment of Hematology, The Eighth Affiliated Hospital, Southern Medical University (The First People's Hospital of Shunde, Foshan), Foshan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: T-cell engagers (TCEs), "off-the-shelf" immunotherapies are seeing widespread clinical application, yet their real-world safety profile is not fully defined. This study aimed to characterize the comprehensive adverse event (AE) profile of TCEs, using chimeric antigen receptor T-cell (CAR-T) therapy as a contextual benchmark. Methods: A pharmacovigilance study was conducted on AE reports for TCE and CAR-T therapies from FAERS and VigiBase. A multi-level analytical framework integrated disproportionality analysis, time-to-onset modeling, occurrence network analysis, and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) analysis to characterize signals, temporal dynamics, and clinical syndromes. Results: The proportion of fatal outcomes reported with TCEs significantly increased from 14.3% in 2015 to 23.5% in 2025 (P<0.001). Compared to CAR-T, TCEs showed stronger signals for Infection and Tumor Lysis Syndrome (TLS), while CAR-T showed stronger signals for Cytokine Release Syndrome (CRS) and ICANS. TLS and CRS occurred significantly earlier with TCEs. Network analysis quantified the co-occurrence and clinical severity of the CRS-ICANS-infection triad. The TCE class showed profound drug-specific heterogeneity, including severe oral/nail toxicities with talquetamab (oral toxicity ROR = 6066.40) and extramedullary relapse/infiltration with blinatumomab. TCE-associated ICANS revealed a strong overall signal (ROR 197.08), with fatal outcomes reported in 26% of cases, an early-peaking reporting pattern (WSP α = 0.63), and key risk factors including age, indication, target and concurrent CRS. Conclusion: TCEs are characterized by rapid early CRS/TLS AEs, elevated infection reporting, and target-specific toxicities, while CAR-T exhibits stronger CRS/ICANS signals. These findings support early monitoring and molecule-specific, syndrome-based risk management, advancing precision pharmacovigilance for T-cell redirecting therapies.

Indexed as

Adverse Drug Reaction Reporting SystemsImmunotherapy, AdoptiveReceptors, Antigen, T-CellReceptors, Chimeric AntigenT-LymphocytesCytokine Release SyndromeHumansMultilevel AnalysisNeurotoxicity SyndromesOff-Label UsePharmacovigilanceRetrospective StudiesTumor Lysis Syndromecell-associated neurotoxicityReceptors, Antigen, T-CellReceptors, Chimeric Antigenchimeric antigen receptor t-cell therapyimmune effector cell-associated neurotoxicity syndromepharmacovigilancereal-world evidenceT-cell engager

Identifiers

PMID41869330
PMCPMC13002793

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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 Socratic graph.