The U.S. Food and Drug Administration (FDA) has granted fast track designation to CAR T-cell therapy ADI-001 as a potential treatment for lupus nephritis, a lupus complication marked by kidney damage and inflammation. The FDA gives fast track status to experimental treatments that have the potential to fill unmet…
The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is joining the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to focus on CAR T-cell treatments and other engineered cell therapies, a promising new therapeutic field now being explored for lupus. “We are delighted to have…
Treatment with the investigational injection therapy itolizumab significantly reduced urine protein levels, a marker of kidney dysfunction, in people with active lupus nephritis, a serious lupus complication marked by kidney damage and inflammation. That’s according to top-line results from a Phase 1b trial called EQUALISE (NCT04128579) that were…
An arm of China’s National Medical Products Administration has given Kezar Life Sciences the green light to open sites in China for a Phase 2 clinical trial testing zetomipzomib in people with lupus nephritis, a severe complication of lupus characterized by kidney inflammation and damage. Kezar will run…
The first participant has been treated in a Phase 1 clinical trial testing the CAR T-cell therapy CC-97540 (BMS-986353) in people with severe systemic lupus erythematosus (SLE). “The opportunity to provide lupus patients with access to this treatment, all while ensuring they receive the highest level of care, is…
The antimalarial agent hydroxychloroquine doesn’t appear to lower the risk of preeclampsia during pregnancy in women with lupus, a study reports. The study, “Hydroxychloroquine in lupus pregnancy and risk of preeclampsia,” was published in Arthritis & Rheumatology. Preeclampsia is a pregnancy complication marked by high…
Scientists have created small molecules that can block the activity of SLC15A4, an inflammatory protein — long considered undruggable — that’s known to play a central role in driving lupus and other autoimmune diseases. Further, the team showed that these molecules could reduce inflammation in lupus patient cells and…
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…
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,…