NEW YORK – Kyverna Therapeutics on Thursday said it has enrolled the first patient in a Phase I clinical trial of its autologous CAR T-cell therapy for refractory lupus nephritis, a serious complication of lupus.
KYV-101 aims to modify a patient's own immune T cells to target CD19, a protein expressed on the surface of B cells. Although B cells produce antibodies that are critical for the immune system, they can become overactive in autoimmune diseases, leading the cells to attack other tissues. KYV-101 is designed to modify T cells so that they can recognize and deplete B cells in the patient's body.
Investigators in the Phase I open-label, dose-escalation trial aim to enroll nine to 12 patients with refractory lupus nephritis across multiple sites. The primary goal is to assess the safety of KYV-101.
The US Food and Drug Administration earlier this month granted Emeryville, California-based Kyverna fast-track designation for KYV-101 in its lupus nephritis indication. Kyverna said it is continuing to study KYV-101 in other B-cell driven autoimmune diseases.