{
  "abstract": "Background and Importance Our university hospital has been involved as a sponsor since the early stages of CAR-T clinical trial development, allowing us to put our experience into perspective and illustrate the central role we play in this therapeutic innovation. CAR-T cell therapy is a major breakthrough in the management of haematologic malignancies, but its use is associated with severe adverse events requiring specific management. One of the most frequent and potentially serious complications is cytokine release syndrome (CRS). CRS results from massive immune activation following CAR-T cell infusion, leading to excessive cytokine release, particularly interleukin-6 (IL-6). This inflammatory reaction can rapidly progress to severe multiorgan failure, requiring urgent treatment.Aim and Objectives To compare the incidence, severity, and management of CRS after CAR-T infusion in clinical trials versus standard-of-care patients at our university hospital.Material and Methods We retrospectively reviewed all patients who received CAR-T therapy between 1 January 2020 and 1 July 2025, distinguishing participants in clinical trials (n = 40) from real-life patients (n = 361). Demographics, indications, the occurrence of adverse events (CRS, ICANS), and their management (tocilizumab, corticosteroids) were analysed.Results CRS occurred in 50% (20/40) of trial patients and 83.9% (303/361) of real-life patients. The mean onset was earlier in clinical trials (1.55 days) than in real life (2.64 days). Duration was shorter in trials (3.67 days) than in routine care (6.65 days) (p = 0.0001). Grade ≥ 3 CRS was uncommon in both groups (10% in trials vs 1% in real life). Tocilizumab was administered in all trial cases (20/20) versus 66% (200/303) in routine care, with a longer delay to the first dose in clinical trials (3.7 vs 2 days). Five patients died in the real-life group whereas none in clinical trials. The number of tocilizumab doses differed significantly (2.5 per patient in trials vs 1.9 in routine care; p = 0.0031) with a similar dosage (555.2 mg vs 581.3 mg).Conclusion and Relevance CRS incidence and severity after CAR-T therapy were broadly comparable between clinical trials and real-life practice, but supportive measures were implemented later outsideConflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "E Blaisonneau"
    },
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "C Hamon"
    },
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "R Wilson"
    },
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "N Le Bras"
    },
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "V Jaspart-Le Du"
    },
    {
      "affiliations": [
        "Centre Hospitalo-Universitaire De Rennes, Ille-Et-Vilaine, Rennes, France"
      ],
      "name": "A Chanat"
    }
  ],
  "title": "5PSQ-014 Post cart-T cells crs: clinical trials vs real life",
  "uid": "f0754553-a174-54ae-8a87-552f72b31063"
}