Novartis halts cell-therapy trials after three patient deaths

Three patient deaths have brought Novartis’s experimental rap-cel programme for autoimmune disease under an immediate safety review. The Basel-based pharmaceutical company halted several clinical trials at the end of August after investigators reported three cases of immune effector cell-associated haemophagocytic syndromes. The complications proved fatal, according to a Novartis statement confirmed to AWP and reported by Keystone-SDA on September 1, 2026.

The suspended studies sit in Novartis’s immunology and neuroscience programmes, where researchers are testing whether a powerful cell-based treatment developed in oncology can be redirected against autoimmune disease. The decision removes patients from ongoing trials while the company examines the emerging safety data and considers its next steps.

The announcement carries particular weight in Basel, one of Europe’s major pharmaceutical centres. Novartis employs large research and development operations in Switzerland, and its clinical decisions are closely watched by regulators, investors, hospitals and patients who depend on new treatment options. The company has stressed that the pause does not extend to its cancer programme for rap-cel. That distinction leaves the oncology trials continuing while the autoimmune and neuroscience studies face a detailed reassessment.

Rap-cel is a genetically engineered immune-cell treatment designed to make a patient’s own defences attack diseased cells. Its full name is rapcabtagene autoleucel. The therapy belongs to the CAR-T family, in which white blood cells are collected from a patient and genetically modified so they can recognise and destroy selected target cells before being returned to the body.

CAR-T therapies have become an important area of cancer research because they can produce a highly targeted immune response. Novartis is now testing whether the same basic approach can help reset harmful immune activity in autoimmune diseases, including conditions studied in its immunology and neuroscience programmes.

That power also creates a serious safety challenge. Once activated, engineered cells can produce an intense immune reaction. The source identifies immune effector cell-associated haemophagocytic syndromes as the complication behind the three deaths in the affected trials. In these cases, the immune system’s response can become damaging rather than therapeutic. The company has not released further clinical details in the cited report, including the diseases involved, the patients’ treatment timelines or the precise circumstances of each fatality. Those facts will matter as investigators assess the risk profile of rap-cel outside oncology.

The reported complication is a known risk of powerful CAR-T immune activation, and three fatalities have forced the risk calculation back into focus. CAR-T treatment does not act like a conventional tablet that gradually leaves the bloodstream. It uses living, modified cells that can continue to respond after they are infused into the patient.

That biological activity is central to the treatment’s potential and to its danger. The immune response can cause severe systemic complications, including the haemophagocytic syndromes cited by Novartis. Such reactions require close monitoring and rapid medical intervention in specialised centres. The Swiss report does not provide rates for the complication, nor does it say whether the cases shared a particular disease, dose or patient characteristic.

The decision also follows a wider pattern in the sector. The Wall Street Journal reported the Novartis suspension, while the Swiss report noted that US competitor Bristol-Myers Squibb had previously suspended similar trials as a precaution. That does not establish that the programmes carry identical risks, but it shows why developers treat unexpected immune-related deaths as a trigger for immediate review. For patients considering experimental therapy, the pause underlines the difference between a promising mechanism and a treatment whose safety has been established across a wider population.

The suspension separates Novartis’s autoimmune and neuroscience studies from its cancer trials, leaving the oncology rap-cel programme formally unaffected. That boundary is important for patients and clinicians because CAR-T therapies are assessed programme by programme. A safety signal in one disease area can lead to questions about the platform, while the underlying risk may depend on the target, the dose, the patient population and the treatment protocol.

Novartis said it is carefully evaluating the data that emerged from the affected studies. The company has not announced a timetable for restarting them or described any additional measures. Until that review is complete, people enrolled in the halted trials and those being assessed for participation will need guidance from their treating teams and the relevant trial investigators.

For Swiss hospitals and research centres, the episode highlights the operational demands of advanced cell therapy. These treatments require specialist manufacturing, highly trained staff and systems capable of detecting and managing acute immune complications. The immediate priority is the safety review, while regulators and investigators will examine whether the three cases point to a preventable risk or a broader problem with the treatment approach in autoimmune disease. The public information available so far does not answer that question.

The next decisions will shape confidence in one of Switzerland’s most closely watched areas of drug development. Basel’s pharmaceutical sector has built global influence through complex research, manufacturing and clinical networks. A trial suspension after patient deaths brings those systems under scrutiny, from the way companies identify rare complications to the speed with which they disclose and investigate them.

For patients with serious autoimmune or neurological diseases, experimental cell therapy can represent an option when existing medicines fail. The halt may delay access for people enrolled in the affected studies, although the source does not state how many patients are involved or what alternative treatments are available. Their doctors and trial teams will have to explain what the suspension means for ongoing care and follow-up.

For Novartis, the review will determine whether rap-cel can be modified, whether patient selection or monitoring needs to change, or whether the affected programmes should remain on hold. The oncology trials will proceed outside the announced suspension, according to the company. Swiss regulators, hospitals and investors will watch for the evidence behind the next decision. For now, the confirmed facts are limited but consequential: three patients died, several non-cancer trials stopped, and the company is examining whether the risks of this immune-cell strategy can be controlled in autoimmune disease.