A Phase 1/2 trial, known as the CARAMEL trial, has been announced to assess CNTY-101, an investigational therapy for autoimmune diseases like systemic lupus erythematosus (SLE) and lupus nephritis (LN). The trial, led by Professors Georg Schett and Andreas Mackensen at Friedrich-Alexander University Erlangen-Nürnberg in Germany, marks the first time a therapy based on allogeneic induced pluripotent stem cells (iPSCs) is being studied for autoimmune conditions.
CNTY-101 is a chimeric antigen receptor (CAR) therapy developed to target and eliminate B cells, which are key players in producing autoantibodies and driving disease activity in lupus. The treatment involves enhanced, modified Natural Killer (NK) cells that are engineered to attack diseased and infected cells. Notably, CNTY-101 is the first therapy of its kind with six genetic modifications designed to improve its effectiveness.
The trial will evaluate CNTY-101’s safety and efficacy, as well as provide valuable translational data. Along with SLE and LN, the study will include two additional autoimmune diseases. The approval of the clinical trial application is expected by mid-2025, marking the beginning of this important research.
The Schett/Mackensen group at Erlangen is recognized internationally for their work in cell therapy development for autoimmune diseases, and this trial represents a further step in their ongoing efforts.
