Novartis Pauses Eight Rap-Cel CAR-T Trials After Three Patient Deaths
Novartis temporarily paused eight clinical trials of experimental rap-cel, or rapcabtagene autoleucel (YTB323), a CD19-directed CAR-T therapy being tested in autoimmune and neurological disorders, after three patients died following severe immune-response events. Novartis began a comprehensive safety review with independent study safety boards and shared information with regulators. Oncology studies of rap-cel were continuing.
The supplied Dow Jones report directly supports a new, forward-looking clinical safety development: Novartis temporarily paused eight autoimmune and neurological rap-cel CAR-T trials after three patients died following severe immune-response events, and began a comprehensive safety review with independent safety boards and regulators. The trial holds were reportedly initiated on August 24, 2026; because no exact time is provided, the timestamp uses midnight UTC as a date-level estimate, while the timing of the deaths remains unclear. The development is highly material and surprising because it affects eight studies and can delay enrollment, milestones, and approval probabilities, although oncology studies of rap-cel reportedly continued. Novartis is directly exposed, and Bristol Myers Squibb is retained as an approved stakeholder because the source explicitly reports a precautionary pause of its similar autoimmune CAR-T trials; the more speculative competitor, service-provider, and broader CAR-T impacts are excluded.
Novartis paused eight clinical trials of an experimental therapy targeting autoimmune and neurological disorders in late August, after three patients died.
The Swiss pharmaceutical company temporarily halted the studies after learning of three fatal cases of a severe immune response, a spokesman said.
The company is conducting "a comprehensive review of the observed safety events," said the spokesman
The Swiss drugmaker said it had halted trials for its experimental cell therapy rapcabtagene autoleucel, or rap-cel, in patients with certain autoimmune diseases.
The decision followed three deaths, which the drugmaker linked to immune effector cell-associated hemophagocytic syndrome
Novartis confirmed it paused trials in patients with lupus, myasthenia gravis, multiple sclerosis, and other autoimmune diseases on Aug. 24, as it reviews the safety events.
Novartis paused research into a similar therapy last month, which it confirmed only after a Wall Street analyst noticed while scouring a database.
It took a week for the company to reveal that three study patients had died.
In Novartis's trial, three people died of a rare complication in which the immune system overreacts.