Patient with lupus treated with KYV-101 CAR T-cell therapy relapses after 5 months
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Key takeaways:
- A patient with lupus nephritis who received KYV-101 relapsed 5 months after initially showing a response to the treatment .
- A patient with myasthenia gravis remains drug- and disease-free 1 year after treatment.
A patient with lupus nephritis treated with KYV-101, a chimeric antigen receptor T-cell immunotherapy, saw their disease return 5 months after initially showing a response to the treatment, according to the manufacturer.
The patient, who had a “high BMI,” was treated with a half-dose of 50 million cells, James Chung, MD, PhD, chief medical officer at Kyverna, said during a press conference at the EULAR 2024 Congress.
“There was an early response, with decreased double-stranded DNA and elevation of complement levels, but by the 6-month time-point, those trends reversed,” Chung said. “We don’t really know exactly what happened with this patient, but we do hypothesize that the low dose compared to the high BMI may have contributed.”
During the conference, Kyverna Therapeutics shared safety and efficacy data for their autologous, fully human anti-CD19 CAR T-cell therapy. It has overall shown “a very promising profile” across 50 patients, 30 of whom had autoimmune diseases including lupus nephritis, systemic sclerosis and myasthenia gravis, Chung said.
“To see responses like this, I think, is very encouraging and really points to the potential of the immune reset,” he said.
The first patient treated with KYV-101 had “very refractory” myasthenia gravis, according to Chung. However, since being treated last May, she remains disease-free, with no background immunosuppressants or glucocorticoids, while her B cells have returned, he said.
“After treatment, she actually suddenly improved, with decreasing autoantibodies [and] improvement in her symptoms,” Chung said.
The result “really portends good outcomes for many patients,” he added.
Kyverna CEO Peter Maag, PhD, said there is “not just a will, but there’s a way” to get CAR T-cell treatments through regulatory pathways. He added that the FDA is “looking for ways to work with investigators to make this happen” and has been “very eager to learn about the outcomes that we think are important for patients.”
“I don’t think we know exactly what a pivotal study looks like in CAR-T, but I think we’re pretty close to thinking about what that looks like,” Maag said. “Once you show efficacy, I think we can get to a pivotal study quickly.”
KYV-101 is currently being evaluated for treatment of autoimmune diseases in phase 1/2 and phase 2 trials in the U.S. and Germany, according to a press release from Kyverna.
Reference:
Kyverna Therapeutics to present data on 50 patient experience at symposium at EULAR 2024. https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-present-data-50-patient-experience-0. Published June 7, 2024. Accessed June 14, 2024.
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Press conference
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