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Given the link between haemostasis and inflammation, haemostatic biomarkers could help identify at-risk patients. Sixty-two adult patients receiving CD19- or BCMA-targeted CART were prospectively included and followed up for 30 days to characterize haemostatic changes and evaluate their association with the risk of CRS, ICANS, thrombosis and bleeding. Blood samples were collected at baseline (pre-lymphodepletion), pre-infusion and on days\u2009+\u20093,\u2009+\u200914, and\u2009+\u200928 post-infusion. Haemostatic tests, including thrombin generation assay (TGA, ST-Genesia) and P-Selectin, were performed. CRS occurred in 94% of patients, ICANS in 39%, venous thrombosis in 1.6%, and clinically relevant bleeding in 13%. During follow-up, prolonged coagulation times, thrombocytopenia and decreased fibrinogen and P-selectin, were noted. Baseline endogenous thrombin potential (ETP) was associated with clinically relevant CRS risk (OR 12.39;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.02) and baseline C-reactive protein (CRP) with ICANS (OR 1.66;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.01). Baseline P-selectin levels and platelet count identified patients at higher bleeding risk (OR 0.20;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.03 and OR 0.39;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.01, respectively). In the first month after CART infusion, bleeding incidence exceeds thrombosis. TGA, CRP, platelet count and P-selectin may help identify patients at risk of severe toxicity, enabling earlier, targeted interventions.\n                  <\/jats:p>","DOI":"10.1007\/s00262-026-04371-6","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T11:16:58Z","timestamp":1774955818000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Haemostatic changes during CART cell therapy and risk of complications"],"prefix":"10.1007","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-1918-7675","authenticated-orcid":false,"given":"Mar\u00eda","family":"Panizo-Inog\u00e9s","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Marcos-Jubilar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Ram\u00f3n","family":"Gonz\u00e1lez-Porras","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Puerta-Vazquez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clara","family":"Fern\u00e1ndez-Arias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Rodr\u00edguez-Otero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Alfonso-Pierola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Villar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel \u00c1ngel","family":"Canales","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josune","family":"Orbe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Antonio","family":"P\u00e1ramo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe","family":"Pr\u00f3sper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram\u00f3n","family":"Lecumberri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,31]]},"reference":[{"key":"4371_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.beha.2021.101305","volume":"34","author":"VA Fabrizio","year":"2021","unstructured":"Fabrizio VA, Curran KJ (2021) Clinical experience of CAR T cells for B cell acute lymphoblastic leukemia. 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Participation in Ad Board meetings: BMS, Janssen, Sanofi, Oncopeptides, Pfizer, Roche, Regeneron, H3 Biomedicine and GSK. Consultant: BMS-Celgene, Abbvie, Roche, J&J Innovative Medicines, and Pfizer. Research funding: Pfizer. Travel Support: Pfizer\u2014Ana Alfonso: Honoraria from lectures: Novartis, BMS, Abbvie, Jazz Pharma, Janssen, Astellas. Participation in Ad Board meetings: BMS, Syros, Jazz Pharma, Otsuka, Ascentage Pharma, Janssen. Consultant: Astellas, Jazz Pharma; Janssen. Research Founding: Astra Zeneca\u2014Miguel \u00c1ngel Canales: Speaker fees: Abbvie, Gilead\/Kite, Incyte, J&J, Miltenyi, MSD, Roche, Takeda. Consulting or Advisory role: Beigene, Genmab, Gilead\/Kite, Incyte, J&J, Lilly, Miltenyi, Roche, Takeda. Travel & Accommodations: Gilead\/Kite, J&J, Roche, Takeda. There are no other conflict of interest to disclose.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was approved by the local ethics committee and conducted in accordance with the Declaration of Helsinki.","order":2,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All participants provided written informed consent prior to inclusion.","order":3,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"130"}}