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

医学 双特异性抗体 免疫学 重症监护医学 临床试验 美罗华 德尔菲法 免疫抑制 抗体反应 巨细胞病毒 抗体
作者
Wenyue Cao,fankai meng,S. feng,Mingfeng Zhao,Jianxin Song,Yuqian Sun,Weijie Cao,W. Tian,Yongxian Hu,Fangyi Fan,Xiaowen Tang,Wenbin Qian,Yicheng Zhang,Jia Wei
出处
期刊:Journal of Evidence-based Medicine [Wiley]
卷期号:19 (1): e70107-e70107 被引量:1
标识
DOI:10.1111/jebm.70107
摘要

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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