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Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused

Novartis and Bristol Myers Squibb have paused autoimmune CAR-T cell therapy trials following three patient deaths in Novartis studies.

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The brief

Novartis has paused its CAR-T studies focusing on immunology and neuro-related conditions after three patients died. This halt affects autoimmune cell therapy studies conducted by the company. Concurrently, Bristol Myers Squibb has also paused its own autoimmune CAR-T programs. These combined actions indicate a significant disruption to current clinical trials involving these specific cell therapies, as both companies move to stop patient dosing or study progression in response to emerging safety concerns. Coverage of these pauses has been widespread across pharmaceutical and financial news outlets.

FirstWord Pharma reports that the pauses specifically hit Novartis's immunology and neuro CAR-T studies. The Wall Street Journal confirms that Novartis has paused autoimmune cell therapy studies following the deaths. BioPharma Dive, Fierce Biotech, and Endpoints News all report that both Novartis and Bristol Myers Squibb have implemented these pauses, citing safety concerns as the primary driver for the decision to halt the trials across these different programs. The context of these pauses centers on the application of CAR-T cell therapy to autoimmune diseases. While traditionally used in other contexts, these trials were exploring the use of engineered cells for immunology and neuro-related conditions.

The sudden halt of studies by two major players, Novartis and Bristol Myers Squibb, underscores the high stakes and potential risks associated with applying this technology to autoimmune treatments. The death of three patients in the Novartis trials serves as the immediate catalyst for this industry-wide caution. Looking forward, observers will be monitoring whether these pauses become permanent or if the trials resume after safety protocols are adjusted. Coverage from the listed outlets does not yet specify the exact nature of the safety concerns beyond the three deaths at Novartis. Future updates will likely focus on the results of any investigations into the causes of the patient deaths and whether Bristol Myers Squibb's pause is linked to the same specific triggers as those encountered by Novartis.

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Quick answers

Which companies have paused their trials?

Novartis and Bristol Myers Squibb have both paused their autoimmune CAR-T trials.

How many deaths occurred in the Novartis trials?

Three patient deaths have been reported in the Novartis studies.

Which specific areas of study were affected at Novartis?

Novartis has paused its immunology and neuro CAR-T studies.

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