Kyverna Makes Progress Evaluating Lupus Nephritis Cell Therapy in US, Germany


Phase 1/2 trials have been cleared in Germany and dosed first patients in the US.

Kyverna Therapeutics has received regulatory clearance in Germany to initiate a phase 1/2 clinical trial of KYV-101 chimeric antigen receptor (CAR) T-cell therapy in patients with lupus nephritis.1

"This approval recognizes the potential impact novel CD19 CAR T-cell therapies may bring to patients living with aggressive autoimmune diseases and reflects the global potential for KYV–101. We believe in changing the treatment paradigm by generating rigorous clinical data, and the PEI's approval paves the way to generate additional insights." Peter Maag, PhD, chief executive officer, Kyverna Therapeutics, said in a statement.1

The announcement follows Kyverna’s June update that its United States (US) phase 1/2 trial (NCT05938725) of KYV-101 for the same indication dosed its first patient with lupus nephritis.2 KYV-101 is a CD19-targeted CAR T-cell therapy designed to treat B cell-driven autoimmune diseases. It has previously been evaluated in a phase 1 clinical trial (NCT02659943) in 20 patients with B-cell lymphomas and chronic lymphocytic leukemia sponsored by the National Cancer Institute. The study demonstrated anti-lymphoma activity which was associated with a reduction in cytokine-driven adverse events, including immune effector cells-associated neurotoxicity syndrome (ICANS). The cell therapy also showed reduced immunogenicity which had a beneficial effect on cell persistence at 1 month.

READ MORE: Artiva Biotherapeutics’ NK Cell Therapy AlloNK Cleared for Trial in Systemic Lupus Erythematosus

Kyverna Therapeutics obtained worldwide rights to the therapy from the National Institutes of Health for the use in autologous and allogeneic CAR-T therapies and believe the construct has potential for the treatment of patients with autoimmune diseases, including lupus nephritis. Notably, KYV-101 is a fully human therapy, which may be better tolerated by patients with autoimmune disorders. Traditional anti-CD19 CAR-T cells have relied on mouse-derived CD19 which can cause significant immune reactions against the foreign mouse proteins and generate significant cytokine release.

“We are immensely proud to have reached this significant milestone in our journey to transform the lives of patients battling life-altering ailments such as LN. Our KYV-101 cell therapy has the potential to revolutionize treatment for individuals suffering from autoimmune diseases, with patients currently being treated for multiple indications across the US and Europe. We look forward to advancing our clinical programs so we can bring a new option to patients as quickly as possible,” Maag said in an earlier statement.2

1. Kyverna Therapeutics announces regulatory approval of phase 1/2 clinical trial for KYV-101 in Germany. Kyverna Therapeutics. News release. July 6, 2023.
2. Kyverna Therapeutics announces first patient enrolled in phase 1 clinical trial of CD19 CAR T-cell therapy for Lupus Nephritis in the U.S. News release. Kyverna Therapeutics. June 29, 2023.
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