Bleeding and thrombosis in patients receiving chimeric antigen receptor T-cell therapy

Chimeric antigen receptor (CAR) T-cell therapy has transformed the management of relapsed or refractory hematologic malignancies but is accompanied by immune-mediated toxicities that may disrupt hemostatic balance. In addition to cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and cytopenias, emerging data suggest an increased incidence of both thrombotic and bleeding complications following CAR T-cell infusion. We conducted a narrative review to evaluate the incidence, timing, risk factors, mechanisms, and management of CAR T-cell–associated coagulopathy, including 5 phase III randomized controlled trials and 11 observational studies published after 2020. Venous thromboembolism (VTE) was the most frequently reported thrombotic event, with rates ranging from 0.48–3.26% in trials and 2.1–10.8% in observational cohorts, typically occurring within the first 30–90 days post-infusion and often overlapping with CRS or ICANS. Arterial events were less common (<2%). Reported bleeding rates were low in trials (0–1.85%) but higher in observational studies (2.8–12.5%), frequently associated with thrombocytopenia, hypofibrinogenemia, and markers of endothelial activation. Anticoagulation for established VTE did not appear to confer excess major bleeding in limited series. Current evidence does not support routine thromboprophylaxis for all CAR T-cell recipients. Instead, thrombotic and hemorrhagic risks appear intertwined and temporally dynamic, driven by inflammation, endothelial injury, and cytopenias. Prospective studies incorporating standardized endpoint adjudication and risk stratification are needed to inform individualized prevention and management strategies.

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Publication Details

Journal
Bleeding Thrombosis and Vascular Biology
Published
2026-04-16
DOI
https://doi.org/10.4081/btvb.2026.461
Primary Topic
CAR-T cell therapy research
Type
article
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article

Bleeding and thrombosis in patients receiving chimeric antigen receptor T-cell therapy

Pedro Luiz Lage Bodour Danielian, Avi Leader, Dana Lee
Bleeding Thrombosis and Vascular Biology
CAR-T cell therapy research
article

Bleeding and thrombosis in patients receiving chimeric antigen receptor T-cell therapy

Pedro Luiz Lage Bodour Danielian, Avi Leader, Dana Lee
article en

Abstract

Chimeric antigen receptor (CAR) T-cell therapy has transformed the management of relapsed or refractory hematologic malignancies but is accompanied by immune-mediated toxicities that may disrupt hemostatic balance. In addition to cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and cytopenias, emerging data suggest an increased incidence of both thrombotic and bleeding complications following CAR T-cell infusion. We conducted a narrative review to evaluate the incidence, timing, risk factors, mechanisms, and management of CAR T-cell–associated coagulopathy, including 5 phase III randomized controlled trials and 11 observational studies published after 2020. Venous thromboembolism (VTE) was the most frequently reported thrombotic event, with rates ranging from 0.48–3.26% in trials and 2.1–10.8% in observational cohorts, typically occurring within the first 30–90 days post-infusion and often overlapping with CRS or ICANS. Arterial events were less common (<2%). Reported bleeding rates were low in trials (0–1.85%) but higher in observational studies (2.8–12.5%), frequently associated with thrombocytopenia, hypofibrinogenemia, and markers of endothelial activation. Anticoagulation for established VTE did not appear to confer excess major bleeding in limited series. Current evidence does not support routine thromboprophylaxis for all CAR T-cell recipients. Instead, thrombotic and hemorrhagic risks appear intertwined and temporally dynamic, driven by inflammation, endothelial injury, and cytopenias. Prospective studies incorporating standardized endpoint adjudication and risk stratification are needed to inform individualized prevention and management strategies.

Bleeding Thrombosis and Vascular BiologyVol. 5(s1)
Beth Israel Deaconess Medical Center (US), Memorial Sloan Kettering Cancer Center (US), Cornell University (US), Hadassah Medical Center (IL)
Good health and well-being
Openalex Percentile: Top 23%
CAR-T cell therapy research
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Bleeding and thrombosis in patients receiving chimeric antigen receptor T-cell therapy — Pedro Luiz Lage Bodour Danielian, Avi Leader, et al. · Bleeding Thrombosis and Vascular Biology (2026) | TGRS Research Map | TGRS