Published : 11 Nov 2026, 06:20 PM
Updated : 11 Nov 2026, 06:20 PM
Lupus patients struggling with the debilitating disease are lining up to try experimental CAR-T therapies even after the recent deaths of four patients in clinical trials for a variety of autoimmune diseases, according to doctors who treat the life-threatening condition.
The trials remain halted and full details of the deaths -- three linked to Novartis and one to Bristol Myers Squibb -- have not been released.
Still, patients are willing to take the risk, compelled by accounts of people with advanced disease who were able to stop all medications and reclaim normal lives.
"I have patients that are literally waiting to get in," said Dr Anca Askanase, chief of rheumatology at the Hospital for Special Surgery in New York, who has enrolled patients in the Bristol Myers CAR-T trials.
Systemic lupus erythematosus, or SLE, the most common and severe form of lupus, causes agonising joint pain and raises the risk of stroke, heart attack and kidney disease. Current treatments, ranging from steroids to immunosuppressants and targeted biologics, often fail to control the disease. Some 10 to 15 percent of people with lupus die prematurely.
Brittan Kopittke, 27, who works for the University of North Carolina helping to counsel patients considering CAR-T, was diagnosed with lupus at age 22. SLE affects about 300,000 people in the US and typically develops between the ages of 15 and 44.
What began as a rash on her chest rapidly progressed to crippling joint pain, mouth sores and crushing fatigue. Steroids to reduce inflammation and the antimalarial drug hydroxychloroquine, used to suppress antibodies attacking healthy cells and tissues, failed.
"My mouth sores were rampant. I was struggling to eat. I was struggling to drink. I was just very, very miserable," she said.
Despite trying a combination of medicines, her disease advanced, attacking her kidneys, heart and lungs.
"I had reached the end of the line with treatments,” she said.
In June 2024, Kopittke joined a trial at UNC-Chapel Hill testing CAR-T, a personalised immunotherapy successfully used to treat blood cancers. The treatment involves removing T cells from a patient's blood, genetically re-engineering them to attack rogue immune cells and reinfusing them to encourage the growth of healthy immune cells.
Kopittke developed two dangerous reactions: cytokine release syndrome, which causes systemic inflammation, and a life-threatening, high-grade neurological complication called ICANS that left her unresponsive for three days.
Now, nearly two years into remission, Kopittke said she does not "sugarcoat" the risks when advising patients. "But I do say that I would do this again."
Novartis, Bristol Myers and other companies with approved CAR-T cancer therapies, including Johnson & Johnson and Gilead, are testing the technology against other hard-to-treat diseases.
About 150 trials are underway exploring CAR-T treatment for lupus, alongside many others targeting myasthenia gravis, scleroderma, myositis, multiple sclerosis and stiff-person syndrome.
"There's billions and billions of dollars pouring into this space,” said PJ Utz, a Stanford Medicine autoimmunity researcher.
The risks became clear in late August, when Novartis said it had halted eight trials of its experimental rap-cel CAR-T therapy for autoimmune and neurological disorders after three patients died from a rare but known hyperinflammatory complication called IEC-HS.
Novartis said in an emailed statement that it was working with investigators and external academic experts to understand the cause of the deaths. It would share its findings "once the analysis is completed and the results can contribute to furthering patient care".
Bristol Myers also paused enrolment in its CAR-T autoimmune trials, citing temporary inflammatory events in patients. On Oct 23, it announced the death of a multiple sclerosis patient in one of the trials, but said it had identified the cause of the safety issue and hoped to resume testing in 2027.
The deaths in the Novartis trials surprised doctors eager to try CAR-T, encouraged by the success of Georg Schett of the University of Erlangen-Nuremberg. In 2022, Schett published a paper in the New England Journal of Medicine showing that five lupus patients had achieved remission with CAR-T. Subsequent studies showed that the remission could last.
The Novartis deaths have left doctors in the dark, Schett said. The company needs to disclose which diseases the patients had, how well controlled their conditions were and what emergency treatments they received, he added.
Without those details, doctors enrolling patients in other trials are left to speculate. "This is very sad for the community."
Schett said he and CAR-T inventor Carl June of the University of Pennsylvania had tried to piece together what happened in the Novartis trials for an article submitted to the New England Journal of Medicine.
He attributed the rare hyperinflammatory events partly to Novartis' compressed manufacturing process, which cuts the time needed to produce the cells from more than 10 days to fewer than two.
With this process, patients receive cells in an immature form, which Schett suggested could trigger a severe inflammatory response as the cells expand in the body. "We don't see that in other programmes," he said.
He and others were less concerned about the more familiar side effects reported by Bristol Myers.
"We have treated high-grade inflammatory events that have been reversible with treatment," said Kopittke's doctor, Saira Sheikh, of the University of North Carolina, who chairs a network of nearly 70 lupus clinical trial centres.
Dr Cuoghi Edens, a rheumatologist at the University of Chicago Medicine, which treats more than 100 paediatric lupus patients, said her hospital had achieved considerable success with a CAR-T therapy from Cabaletta Bio, which uses a more traditional manufacturing process.
Cabaletta has begun testing its treatment in patients as young as 12. Edens said she had walked through the informed consent process with a 15-year-old late last month.
"When the potential long-term impact of your diagnosis is death," Edens said, "I don't know if (treatment risks are) going to make that big of a difference to these patients."
