Novartis and BMS Pause Autoimmune CAR T Trials Over Safety Concerns

Three deaths linked to immune effector cell-associated hemophagocytic syndrome prompt Novartis to halt eight rap-cel studies

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Novartis paused eight clinical trials of rapcabtagene autoleucel due to safety concerns after three patients developed serious IEC-HS.
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All three patients affected by IEC-HS during Novartis trials died, prompting a review of safety data with independent boards.
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The paused Novartis trials include phase II studies for systemic lupus erythematosus and other autoimmune diseases.
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Bristol Myers Squibb paused enrollment in trials of zolacabtagene autoleucel after observing transient inflammatory events.
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Both companies are reviewing safety data while monitoring patients already treated in their respective trials.

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