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Peer-reviewedCC BYFrontiers in immunology

Case Report: Severe multi-organ damage induced by cadonilimab: mechanism investigation and management strategies

  1. 1Department of Pharmacy, the Fourth Hospital of Hebei Medical University, Shijiazhuang , ,
  2. 2Department of Pharmacy, the Second Hospital of Hebei Medical University, Shijiazhuang , ,

Abstract

Most immune checkpoint inhibitors currently used in clinical practice, such as programmed cell death protein 1/programmed death ligand 1 (PD 1/PD L1) inhibitors and cytotoxic T lymphocyte antigen 4 (CTLA 4) inhibitors, are monospecific antibodies acting on a single target. In contrast, bispecific antibodies (BsAbs) contain an additional specific antigen binding site, enabling dual signaling pathway blockade and more potent inhibition of tumor growth. In June 2022, the first PD 1/CTLA 4 BsAb cadonilimab (AK104) was approved by the National Medical Products Administration of China for the treatment of cervical cancer and gastric or gastroesophageal junction adenocarcinoma. Owing to its recent market approval, only a limited number of studies have reported immune related adverse events (irAEs) associated with this drug, involving the skin, gastrointestinal tract, liver, and other organs. Thus far, no case of cadonilimab related multi organ injury has been described. In this article, we report the first case of severe immune related multi organ and endocrine system injury induced by cadonilimab in the treatment of cervical cancer. In addition, we conducted a retrospective literature analysis comparing the adverse drug reaction (ADR) profiles of immune checkpoint inhibitor monospecific antibodies and BsAbs. The aim of this analysis was to provide a reference for the rational use of cadonilimab. Early recognition of irAEs, identification of risk factors, regular monitoring, use of corticosteroids, and supportive care are critical for improving clinical outcomes. It should be emphasized that the oncologic benefits of BsAb therapy generally outweigh the risks of ADRs, and treatment should not be discontinued or delayed except in rare circumstances (e.g., multi organ failure). In case of ADR occurrence, familiarity of the healthcare professionals with the relevant irAEs is essential to facilitate effective diagnosis and appropriate management of this increasingly common pattern of multi organ injury.

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BibTeX
@article{shan2026case,
  title = {{Case Report: Severe multi-organ damage induced by cadonilimab: mechanism investigation and management strategies}},
  author = {Bin Shan and Ruixia Yang and Yi Peng and Mengjiao Li},
  journal = {Frontiers in immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1961670},
  url = {https://europepmc.org/article/PMC/PMC13668865},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Case Report: Severe multi-organ damage induced by cadonilimab: mechanism investigation and management strategies
AU  - Bin Shan
AU  - Ruixia Yang
AU  - Yi Peng
AU  - Mengjiao Li
PY  - 2026
DA  - 2026/10/01
JO  - Frontiers in immunology
DO  - 10.3389/fimmu.2026.1961670
UR  - https://europepmc.org/article/PMC/PMC13668865
AB  - Most immune checkpoint inhibitors currently used in clinical practice, such as programmed cell death protein 1/programmed death ligand 1 (PD 1/PD L1) inhibitors and cytotoxic T lymphocyte antigen 4 (CTLA 4) inhibitors, are monospecific antibodies acting on a single target. In contrast, bispecific antibodies (BsAbs) contain an additional specific antigen binding site, enabling dual signaling pathway blockade and more potent inhibition of tumor growth. In June 2022, the first PD 1/CTLA 4 BsAb cadonilimab (AK104) was approved by the National Medical Products Administration of China for the treatment of cervical cancer and gastric or gastroesophageal junction adenocarcinoma. Owing to its recent market approval, only a limited number of studies have reported immune related adverse events (irAEs) associated with this drug, involving the skin, gastrointestinal tract, liver, and other organs. Thus far, no case of cadonilimab related multi organ injury has been described. In this article, we report the first case of severe immune related multi organ and endocrine system injury induced by cadonilimab in the treatment of cervical cancer. In addition, we conducted a retrospective literature analysis comparing the adverse drug reaction (ADR) profiles of immune checkpoint inhibitor monospecific antibodies and BsAbs. The aim of this analysis was to provide a reference for the rational use of cadonilimab. Early recognition of irAEs, identification of risk factors, regular monitoring, use of corticosteroids, and supportive care are critical for improving clinical outcomes. It should be emphasized that the oncologic benefits of BsAb therapy generally outweigh the risks of ADRs, and treatment should not be discontinued or delayed except in rare circumstances (e.g., multi organ failure). In case of ADR occurrence, familiarity of the healthcare professionals with the relevant irAEs is essential to facilitate effective diagnosis and appropriate management of this increasingly common pattern of multi organ injury.
SN  - 1664-3224
ER  -