News

1st CAR T-cell trial in children with lupus in US gets FDA go-ahead

Seattle Children’s has been cleared by the U.S. Food and Drug Administration (FDA) to start the nation’s first clinical trial testing CAR T-cell therapy in children with systemic lupus erythematosus, the most common form of lupus. The trial, Reversing Autoimmunity through Cell Therapy (REACT-01), is targeted for a summer…

AlloNK cell therapy wins FDA fast track status for lupus nephritis

The U.S. Food and Drug Administration (FDA) has granted fast track status to AlloNK, an experimental natural killer (NK) cell therapy, for treating lupus nephritis, when given in combination with rituximab or obinutuzumab. Fast track status is designed to aid the development and accelerate the review of investigational treatments…

Atara asks FDA to clear ATA3219 for clinical testing in lupus nephritis

Atara Biotherapeutics has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for permission to test ATA3219, a CAR T-cell therapy, in clinical trials involving systemic lupus erythematosus (SLE) patients with lupus nephritis. CAR T-cell therapies are based on immune T-cells, which…

First SLE patient dosed in CAR T-cell therapy Phase 1 trial

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…

Most benefit of RSLV-132 seen in patients with more active SLE

Treatment with RSLV-132 failed to lessen the severity and visible damage caused by skin lesions in people with systemic lupus erythematosus (SLE) in a Phase 2 clinical trial. But the experimental RNA-digesting enzyme did tend to ease general symptoms in patients with more active SLE. That’s according to data…

Hydroxychloroquine doesn’t seem to lower lupus preeclampsia risk

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…