Bristol Myers Squibb reported that a patient died after receiving its investigational autoimmune CAR-T therapy in an early Phase 1 trial. The patient experienced motor symptoms that did not resolve with standard autoimmune treatments, received a potent immunosuppressant, then developed septic pneumonia and died. The company’s disclosure adds to heightened safety scrutiny around CAR-T approaches being tested in autoimmune settings. It follows prior public disclosures in the category, including pauses and deaths tied to immune dysregulation in other programs. For trial sponsors and investigators, the key focus now is how safety signals are monitored and mitigated, including immune management protocols, patient selection, and event attribution as more data accumulate.
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