Expert Consensus on Cytomegalovirus Management in Recipients of CAR‐T Cell and Bispecific Antibody Therapies

Cytomegalovirus (CMV) is an increasingly recognized complication of chimeric antigen receptor T-cell (CAR-T) and bispecific antibody (BsAb) therapies for hematologic malignancies, driven by therapy-related immunosuppression and cumulative exposure to lymphodepleting or steroid regimens. Given China's high adult CMV IgG seroprevalence (>90%), baseline risk, interpretation of low-level DNAemia, and operational thresholds differ from low-seroprevalence settings, requiring context-specific guidance. This China-adapted, evidence-graded consensus was developed by a multidisciplinary panel from major centers using a modified Delphi process and Oxford Centre for Evidence-Based Medicine levels to translate international guidance into a high-seroprevalence setting. Recommendations prioritize early risk stratification and pragmatic surveillance. We advise routine CMV monitoring by real-time quantitative PCR during the first 30 days after therapy, with risk-adapted extension thereafter. Interpretation and treatment triggers are anchored to WHO-traceable IU/mL and specified by specimen matrix to support comparability across assays. Consideration of prophylaxis is proposed for well-defined high-risk subgroups, acknowledging the need for prospective validation. Syndrome-based diagnostic and treatment algorithms are provided for tissue-invasive disease, including CMV pneumonia and encephalitis, with guidance on antiviral induction, step-down, and monitoring for virologic response and drug toxicity. This consensus explicitly adapts international recommendations to China's epidemiology, assay practice, and drug accessibility. By standardizing prevention, surveillance, and management in CAR T-cell and BsAb recipients, this consensus aims to lower non-relapse mortality and improve long-term outcomes. Priority research needs include harmonized viral-load thresholds, validation of risk-adapted prophylaxis strategies, and studies that clarify the significance of low-level DNAemia in this population.

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Journal
Journal of Evidence-Based Medicine
Published
2026-01-14
DOI
https://doi.org/10.1111/jebm.70107
Primary Topic
CAR-T cell therapy research
Type
article
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article

Expert Consensus on Cytomegalovirus Management in Recipients of CAR‐T Cell and Bispecific Antibody Therapies

W. Tian, S. feng, J. Wei, Jianxin Song et al.
Journal of Evidence-Based Medicine
CAR-T cell therapy research
article

Expert Consensus on Cytomegalovirus Management in Recipients of CAR‐T Cell and Bispecific Antibody Therapies

W. Tian, S. feng, J. Wei, Jianxin Song, P Li, Fangyi Fan, fankai meng, Wenbin Qian, Weijie Cao, Xiaowen Tang, Yuqian Sun, Yongxian Hu, Yicheng Zhang, Wenyue Cao
article en

Abstract

Cytomegalovirus (CMV) is an increasingly recognized complication of chimeric antigen receptor T-cell (CAR-T) and bispecific antibody (BsAb) therapies for hematologic malignancies, driven by therapy-related immunosuppression and cumulative exposure to lymphodepleting or steroid regimens. Given China's high adult CMV IgG seroprevalence (>90%), baseline risk, interpretation of low-level DNAemia, and operational thresholds differ from low-seroprevalence settings, requiring context-specific guidance. This China-adapted, evidence-graded consensus was developed by a multidisciplinary panel from major centers using a modified Delphi process and Oxford Centre for Evidence-Based Medicine levels to translate international guidance into a high-seroprevalence setting. Recommendations prioritize early risk stratification and pragmatic surveillance. We advise routine CMV monitoring by real-time quantitative PCR during the first 30 days after therapy, with risk-adapted extension thereafter. Interpretation and treatment triggers are anchored to WHO-traceable IU/mL and specified by specimen matrix to support comparability across assays. Consideration of prophylaxis is proposed for well-defined high-risk subgroups, acknowledging the need for prospective validation. Syndrome-based diagnostic and treatment algorithms are provided for tissue-invasive disease, including CMV pneumonia and encephalitis, with guidance on antiviral induction, step-down, and monitoring for virologic response and drug toxicity. This consensus explicitly adapts international recommendations to China's epidemiology, assay practice, and drug accessibility. By standardizing prevention, surveillance, and management in CAR T-cell and BsAb recipients, this consensus aims to lower non-relapse mortality and improve long-term outcomes. Priority research needs include harmonized viral-load thresholds, validation of risk-adapted prophylaxis strategies, and studies that clarify the significance of low-level DNAemia in this population.

Journal of Evidence-Based Medicine
Ministry of Education of the People's Republic of China (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Tianjin First Center Hospital (CN), Soochow University (CN), Hubei Provincial Center for Disease Control and Prevention (CN), Chengdu Military General Hospital (CN), Peking University People's Hospital (CN), Institute of Hematology & Blood Diseases Hospital (CN), First Affiliated Hospital of Soochow University (CN), First Affiliated Hospital of Zhengzhou University (CN), Second Affiliated Hospital of Zhejiang University (CN), Shanxi Academy of Medical Sciences (CN), Tongji Hospital (CN), Huazhong University of Science and Technology (CN), Tianjin Medical University (CN), Zhejiang University (CN)
Good health and well-being
Openalex Percentile: Top 88%
CAR-T cell therapy research
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