The U.S. Food and Drug Administration (FDA) has cleared a clinical trial to evaluate the safety and preliminary effectiveness of CB-010, Caribou Biosciences’ investigational CAR T-cell therapy, for lupus that affects the kidneys and other organs. The multicenter Phase 1 trial, dubbed GALLOP, should begin by the end…
The U.S. Food and Drug Administration (FDA) has granted permission for Atara Biotherapeutics to test its lupus nephritis treatment candidate ATA3219 in a Phase 1 clinical trial involving lupus patients with this complication, which is marked by kidney damage and inflammation. The first patient is expected to be…
Modified anti-inflammatory T-regulatory immune cells, known as Tregs, were able to suppress autoimmune activity in cells and in a mouse model of lupus nephritis, a common complication of lupus marked by kidney inflammation, a new study reports. These findings support the development of a Treg-based treatment that uses a…
Brepocitinib, an investigational oral therapy, failed to show any benefits beyond a placebo in a Phase 2 clinical trial that tested it in adults with moderate to severely active systemic lupus erythematosus (SLE). As such, the trial failed to meet its primary objective, as assessed using the SLE Responder…
Adding Gazyva (obinutuzumab) to standard-of-care therapy for two years reduced the risk of treatment failure, diminished kidney function or death by 60% in people with lupus nephritis, a lupus complication marked by kidney inflammation and damage. The number of lupus nephritis flares, or periods of sudden worsening, also…
The U.S. Food and Drug Administration (FDA) has approved Nkarta’s request to launch a clinical trial in the U.S. to test its experimental therapy NKX019 in people with lupus nephritis, a lupus complication marked by kidney inflammation and damage. The multi-center, dose-escalation study will assess the safety and clinical…
No signs of neurotoxicity were seen for 28 days after the first patient in a Phase 1 clinical trial was dosed with KYV-101, Kyverna Therapeutics’ investigational cell therapy for lupus nephritis, a lupus complication marked by kidney damage. A standard 4-week post-infusion observation period in such clinical trials is…
Kyverna Therapeutics will use Verily Life Sciences’ high-resolution Immune Profiler to identify biomarkers to measure responses to KYV-101, Kyverna’s experimental cell therapy for lupus-related kidney disease. KYV-101 is being evaluated in an open-label trial, which is recruiting nine to 12 patients at clinical sites across the U.S.
Racial discrimination was found to be associated with increased inflammation among Black women with systemic lupus erythematosus (SLE) in a recent study. Each experience of racial discrimination was tied to a nearly 4% increase in the levels of C-reactive protein (CRP), an inflammation marker, in the bloodstream, the findings…
A Phase 2b clinical trial of ESK-001, an oral treatment for systemic lupus erythematosus (SLE), has begun dosing patients, according to its developer Alumis. The trial, called LUMUS, is expected to enroll about 388 adults with moderately to severely active SLE who test positive for self-reactive antibodies (autoantibodies).