Investigator-initiated Study of CNTY-101, for People with Autoimmune Diseases, Including Systemic Lupus Erythematosus and Lupus Nephritis Announced

An investigator-initiated Phase 1/2 trial of CNTY-101, an  investigational therapy, has been announced for the treatment of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE) and lupus nephritis (LN). The trial, named the CARAMEL trial, will be led by Professors Georg Schett and Andreas Mackensen at Friedrich-Alexander University Erlangen-Nürnberg in Germany. This is the first study conducted by the internationally recognized Schett/Mackensen group to explore allogeneic induced pluripotent stem cells (iPSCs) derived CD19-directed Natural Killer (NK) cell therapy for the treatment of autoimmune diseases.

The CARAMEL trial aims to evaluate the safety, efficacy, and key translational data of CNTY-101 in SLE, LN, and two additional diseases. CNTY-101 is a chimeric antigen receptor (CAR) therapy derived from iPSCs. This therapy is engineered to target and eliminate B cells, which play a critical role in the production of autoantibodies and lupus disease activity. CNTY-101 is made of enhanced modified immune NK cells (or lymphocytes) which help destroy infected and diseased cells in the body. It is the first therapy engineered with six gene edits. The trial will begin upon approval of the clinical trial application, expected mid-2025.

The Schett/Mackensen group at Erlangen is recognized for pioneering the development of cell therapy in autoimmune diseases. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.

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