The U.S. Food and Drug Administration (FDA) has granted fast track status to ADI-001, Adicet Bio’s CAR T-cell therapy for systemic lupus erythematosus (SLE) that’s resistant to available treatments, the company announced in a press release. The designation follows the FDA’s award last year of fast track…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Caribou Biosciences‘ CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE) — the most common form of lupus — that’s resistant to available treatments, the company announced in a press release. This designation is…
Patient screening is underway in a U.S.-based clinical trial of NKX019, an investigational natural killer (NK) cell therapy for people with treatment-resistant lupus nephritis, a serious complication of lupus, its developer, Nkarta, announced. The trial, called Ntrust-1, is a multicenter and open-label study to assess the safety,…
Mutations in the UNC93B1 gene — which produces a protein involved in the regulation of certain immune proteins, called toll-like receptors, or TLRs — may drive autoimmunity in people with lupus and other autoimmune conditions, according to a new study into the genetic cause of lupus and related diseases.
Three women with the autoimmune conditions systemic lupus erythematosus (SLE) and Sjögren’s syndrome saw their symptoms ease after starting a diet rich in plant-based raw foods, according to a recent case series report. The diet included mainly leafy greens, cruciferous vegetables, flax or chia seeds as a source of omega-3…
Immpact Bio has received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) for its ongoing Phase 1b/2 study evaluating the safety and efficacy of IMPT-514 in people with active and treatment-resistant systemic lupus erythematosus (SLE), including those with active lupus nephritis. The open-label…
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 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…
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…
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…