Author Archives: Lindsey Shapiro

Phase 2b clinical trial seeks SLE patients with lupus nephritis

PALIZADE, a Phase 2b clinical trial of Kezar Life Sciences’ investigational therapy zetomipzomib, is still enrolling systemic lupus erythematosus (SLE) patients with active lupus nephritis, a severe lupus complication that causes kidney damage. The launch of the placebo-controlled PALIZADE trial (NCT05781750) earlier this year followed the completion…

Research Alliance awards team $3M to study pediatric lupus nephritis

The Lupus Research Alliance (LRA) has awarded a $3-million grant to a multidisciplinary research group working to identify drivers of lupus nephritis, a serious complication of lupus characterized by kidney damage, in children with the autoimmune disease. Elena Hsieh, MD, an associate professor at the University of Colorado…

Study IDs risk factors for severe lupus flares in patients in Iran

Younger age, greater disease activity, and a history of kidney involvement are significant predictors of severe disease flares among people with systemic lupus erythematosus (SLE), a study in Iran has found. The findings suggest that patients with these risk factors “may need closer monitoring and follow-up” to better manage…

Lupkynis helps protect kidneys with lupus nephritis and high proteinuria

Lupkynis (voclosporin) combined with background lupus treatments better preserved kidney function among a subgroup of lupus nephritis patients with particularly high protein levels in the urine (proteinuria) compared with background therapy alone. Notably, these benefits were observed regardless of patients’ baseline demographic or clinical characteristics, and they were…

Upadacitinib reduces SLE disease activity: Phase 2 trial data

A year of treatment with upadacitinib led to significant disease activity reductions for people with systemic lupus erythematosus (SLE), according to data from the Phase 2 SLEek trial. It was similarly effective when used with the experimental treatment elsubrutinib, in a combination called ABBV-599, the researchers found. These and…

KYV-101 CAR-T cell therapy for lupus nephritis on FDA fast track

KYV-101, an investigational cell therapy from Kyverna Therapeutics, has been granted a fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory lupus nephritis — a serious lupus complication characterized by kidney damage. Fast track status is granted to experimental therapies for…

Phase 1/2 trial of relma-cel, a CAR T-cell therapy, to open in China

JW Therapeutics has received approval from Chinese authorities to open a clinical trial of its CAR T-cell therapy, relmacabtagene autoleucel (relma-cel), in systemic lupus erythematosus (SLE) patients with moderate-to-severe and treatment-resistant active disease. Although not approved for SLE or other autoimmune disorders, relma-cel is available under the…

Cabaletta’s CAR T-cell therapy cleared for SLE Phase 1/2 trial

The U.S. Food and Drug Administration (FDA) has cleared a Phase 1/2 clinical trial to test CABA-201, Cabaletta Bio’s investigational CAR T-cell therapy, in people with systemic lupus erythematosus (SLE) with or without kidney involvement. Cabaletta asked to launch the trial in the form of an investigational new…