SYNCAR-001 + STK-009

SYNCAR-001 + STK-009 is an investigational, two-component, combination cell and cytokine therapy designed for the treatment of autoimmune diseases and hematologic malignancies. SYNCAR-001 is an **autologous CD19-directed chimeric antigen receptor T cell (CAR-T) product expressing an engineered orthogonal interleukin-2 (IL-2) receptor**. STK-009 is an **engineered, pegylated orthogonal IL-2 cytokine** which selectively stimulates only SYNCAR-001 cells due to the matched receptor-ligand design. This targeted cytokine support aims to enable expansion and functional persistence of CAR-T cells without systemic IL-2-related toxicity. The therapeutic goal is robust depletion of pathogenic B cells or CD19+ malignancies without the need for lymphodepleting chemotherapy, representing a differentiated, potentially safer approach compared to conventional CD19 CAR-T regimens. The regimen is being developed primarily by Synthekine and is in phase 1 clinical trials for multiple indications, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, non-Hodgkin lymphoma, and other B cell malignancies[1][2][3][4][7][8].

Other names

autologous hoRb-expressing anti-CD19 CAR T cells SYNCAR-001