UPDATED: First Participant Enrolled in KYV-101 Clinical Trial for Refractory Lupus Nephritis Treatment

This article was updated on July 7 to include information about the first patient enrolled in the KYV-101 Clinical Trial

Kyverna enrolled its first patient in the clinical trial of KVY-101 for the treatment of LN. The Phase 1 open-label clinical trial is actively recruiting patients with lupus nephritis (LN). KYV-101, an investigational drug by Kyverna Therapeutics has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a treatment for refractory lupus nephritis (LN, lupus-related kidney disease in which people do not respond to first-line immunosuppressive drugs or quickly relapse after remission). KYV-101 is a CAR-T cell therapy designed to target B cells (immune system cells involved in the production of autoantibodies and lupus disease activity). Scientists collect T cells from the patient and re-engineer them by introducing chimeric antigen receptors (CARs),  to create CAR-T cells.

Kyverna is currently recruiting participants for the open-labelPhase 1 clinical trial at multiple locations across the U.S. Researchers hope to enroll nine to 12 patients with LN in the study. Additionally, the company filed a parallel Phase 1 / Phase 2 clinical trial with the European Union that will take place in Germany.

Fast Track designation by the FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, like lupus, and fill an unmet need with the goal of getting new drugs to patients sooner. Continue to follow the Lupus Foundation of America for KYV-101 updates, as well as other lupus drug development news. Learn more about medications used to treat lupus.

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