GC Cell said its  U.S. affiliate Artiva Biotherapeutics has begun administering the first dose to a participant in a phase 1 clinical trial. This trial investigates the combination of AlloNK (AB-101) and rituximab as a potential treatment for lupus nephritis.

Lupus nephritis is a complication of systemic lupus erythematosus (SLE). There are an estimated five million people with lupus worldwide, of which approximately 40 percent will develop lupus nephritis. Patients with end-stage lupus nephritis in particular require hemodialysis and kidney transplantation.

AlloNK, which was licensed to Artiva by GC Cell, is an off-the-shelf NK cell therapy derived from cryopreserved umbilical cord blood and received Fast Track designation from the U.S. FDA in February as a combination therapy for lupus nephritis.

“We are excited to bring this innovative treatment option with AlloNK to patients with a variety of autoimmune diseases,” Artiva Biotherapeutics CEO Fred Aslan said. “This is the first patient dose for a clinical trial of an off-the-shelf allogeneic NK cell therapy in the U.S., and previous data of in a B-cell non-Hodgkin lymphoma (B-NHL) trial confirms the reduction in B-cells, demonstrating its applicability to B-cell-related autoimmune diseases.”

Artiva had also previously conducted a phase 1/2 clinical trial using AlloNK with rituximab to treat patients with recurrent or refractory B-cell non-Hodgkin lymphoma (B-NHL).

As of March 26, all 29 patients who participated in the study showed a reduction in peripheral blood B-cell levels to undetectable levels within eight days of starting clinical treatment, except for one patient who showed a decrease on day 15.

Aslan stressed that AlloNK can also be used in combination with single antibodies targeting CD20, CD19, or CD38 to provide treatment for a variety of immune diseases.