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Simvastatin + dexamethasone is a combination prophylactic regimen being investigated by the Masonic Cancer Center at the University of Minnesota to prevent immune effector cell-associated neurotoxicity syndrome (ICANS). This condition is a common and potentially severe side effect in patients receiving axicabtagene ciloleucel (axi-cel) CAR T-cell therapy for relapsed or refractory B-cell lymphoma. The regimen involves the intrathecal administration of dexamethasone, a synthetic glucocorticoid that reduces central nervous system inflammation, and the oral administration of simvastatin, an HMG-CoA reductase inhibitor with potential pleiotropic anti-inflammatory and neuroprotective effects. An early phase 1 study (NCT04514029) is evaluating the safety and feasibility of this approach, with preliminary results suggesting a reduction in severe neurotoxicity compared to historical data.
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