KYV-101 - CD19-directed CAR-T cell therapy
A chimeric antigen receptor (CAR) is a cellular receptor engineered to connect an extracellular targeting function with intracellular domains that activate the cytotoxic potential of T cells. CAR (Chimeric Antigen Receptor) T cells are T cells that have been engineered with additional receptors to identify specific proteins, called antigens, present on the surface of other cells. The Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach is designed to transiently, but fully, eliminate B cells, thus potentially enabling an “immune system reset.” KYV-101 is an autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy.
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How is KYV-101 being studied in Lupus nephritis?
A Phase 1, Open-Label, Multicenter Study of KYV-101, an autologous fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in subjects with Refractory Lupus Nephritis. The primary outcome is the incidence of adverse events and laboratory abnormalities and the frequency of dose-limiting toxicities at each dose level.
Eligibility Criteria
Age ≥18 years
Biopsy-proven proliferative LN Class III or IV according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria