News

China clears Phase 1/2 trial of GC012F in difficult-to-treat SLE

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…

Lupkinis plus MMF most effective in lupus nephritis; tacrolimus safest

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…

NKF launches educational video series for lupus, lupus nephritis

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…

Off-the-shelf CAR cell therapy to enter SLE trial next year

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…