China’s regulatory body has given Gracell Biotechnologies the green light to launch a Phase 1/2 clinical trial testing GC012F, an experimental dual-targeting CAR T-cell therapy, in people with difficult-to-treat systemic lupus erythematosus (SLE). The decision by China’s National Medical Products Administration comes shortly after the U.S. Food and…
A combination of Lupkinis (viclosporin) with mycophenolate mofetil (MMF) was the most effective at managing lupus nephritis, according to a systematic review of clinical trial data. The treatment was also associated with the highest risk of infections and serious infections, indicating a lower safety profile than other immunosuppressive…
A first person has been dosed in a Phase 1 clinical trial of VENT-03, Ventus Therapeutics’ oral treatment candidate for lupus and other inflammatory diseases. VENT-03 is an inhibitor of cGAS, a protein whose activation has been implicated in lupus and other autoimmune diseases. “cGAS has historically proven an…
The Lupus Foundation of America (LFA) will use a three-year federal grant — worth up to $500,000 per year — to continue efforts to increase the number of Black lupus patients in the U.S. who participate in clinical trials. The grant, which runs from September 2023 to September…
Men with systemic lupus erythematosus (SLE) are more likely to experience kidney failure and heart attacks, while women with SLE are at higher risk of other symptoms, such as skin problems and arthritis, according to a new study. “Generally, our study suggests that men have the same spectrum of…
Among people with systemic lupus erythematosus (SLE), those who develop pulmonary arterial hypertension (PAH), or high blood pressure in the vessels that supply the lungs, appear to be younger at diagnosis and have more severe disease, a study in Japan has found. In SLE patients with PAH, immune-suppressing glucocorticoids…
The National Kidney Foundation (NFK) has launched a patient-friendly video series to help patients better understand the association between lupus and lupus nephritis. Marked by kidney inflammation and damage, lupus nephritis is considered to be one of the most severe complications of lupus, since it may compromise the…
The U.S. Food and Drug Administration (FDA) has cleared Century Therapeutics to start a Phase 1 clinical trial that will test its off-the-shelf cell therapy CNTY-101 in people with systemic lupus erythematosus (SLE). The Phase 1 study will enroll people with moderate to severe SLE who’ve failed to respond…
The U.S. Food and Drug Administration (FDA) has given Gracell Biotechnologies the green light to start a Phase 1/2 clinical trial to test its experimental cell therapy GC012F in people with difficult-to-treat systemic lupus erythematosus (SLE). The study’s Phase 1 portion should start in 2024 to assess the safety,…
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…