NEW YORK – Kyverna Therapeutics on Wednesday said it has received permission from the US Food and Drug Administration to begin human trials of its autologous CAR T-cell therapy KYV-101 as a potential treatment for scleroderma.
With the FDA's clearance of its investigational new drug (IND) application, Kyverna will initiate a Phase I/II open-label, multicenter trial, dubbed KYSA-5, to evaluate KYV-101 in adults with diffuse cutaneous systemic sclerosis, a rare and chronic autoimmune disease, also known as scleroderma.
KYV-101 is designed to modify a patient's own T cells to target CD19, a protein expressed on the surface of B cells — a critical component of the immune system that can become overactive in autoimmune diseases. By targeting CD19, Kyverna hopes its cell therapy will enable T cells to recognize and deplete B cells in a patient's body.
"We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals," Kyverna CEO Peter Maag said in a statement. "With the deep B-cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their overactive immune system."
This study in scleroderma represents Kyverna's third IND clearance for KYV-101, which the company is studying in various B-cell driven autoimmune diseases. The Emeryville, California-based firm has also kicked off a Phase I trial in the US and a Phase I/II trial in Germany to evaluate the cell therapy in adults with lupus nephritis.