Will Patient Deaths Derail the CAR-T Train in Autoimmune Disease?
The companies said the pause follows inflammatory side effects and three deaths as they review safety data with regulators and independent boards.
- On Monday, Novartis and Bristol Myers Squibb paused multiple clinical trials evaluating CAR-T cell therapies for autoimmune conditions to investigate inflammatory side effects observed during recent testing.
- Novartis halted eight trials of its experimental rap-cel therapy in late August after learning of three fatal cases of immune effector cell-associated hemophagocytic syndrome, or IEC-HS.
- Bristol Myers paused enrollment for its zola-cel treatment "out of an abundance of caution" to review clinical data, detecting "transient and reversible inflammatory events" during routine safety surveillance.
- William Blair analyst Sami Corwin wrote that production-accelerating technology "could be driving increased cell expansion and the reported toxicities," though she cautioned other factors might also contribute.
- Other firms including Kyverna Therapeutics and Cabaletta Bio continue testing their own CAR-T therapies for autoimmune diseases, remaining at the forefront of research aiming to induce remissions for difficult-to-treat conditions.
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According to a media report, the Swiss pharmaceutical company Novartis has suspended several clinical studies for experimental therapy.
In Switzerland, three study participants died in experimental cell therapy – apparently from a known complication. Novartis has now exposed several studies.
Will Patient Deaths Derail the CAR-T Train in Autoimmune Disease?
(MedPage Today) -- Two Big Pharma companies have reportedly paused their ongoing trials of chimeric antigen receptor (CAR) T-cell therapies in lupus and other autoimmune inflammatory diseases after some participants suffered severe adverse events...
Novartis reported on Tuesday that eight clinical trials of an experimental cell therapy, called rap-cel, aimed at autoimmune and neurological disorders after the death of three patients, were carried out at the end of August. Paralysis was implemented on 24 August, after the pharmacy was notified about three cases of a serious and potentially fatal immune reaction. Complications resulting from this reaction, in which the defense system of the or…
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