News

FDA OKs Phase 1 study of two-component immunotherapy

The U.S. Food and Drug Administration (FDA) has approved a clinical trial to evaluate the safety and effectiveness of Synthekine‘s two-component immunotherapy for the treatment of certain patients with lupus, without using lymphodepletion, a process in which chemotherapy is used beforehand to eliminate disease-causing immune cells. The multicenter, dose…

Lupus Therapeutics, Artiva team up on AlloNK Phase 1 trial

Lupus Therapeutics is collaborating with Artiva Biotherapeutics on a Phase 1 clinical trial testing AlloNK, a natural killer (NK) cell therapy candidate, in patients with lupus nephritis, which is one of the most common and severe complications of lupus that affects the kidneys. With a single clinical…

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…