AbelZeta Secures FDA Go-Ahead for C-CAR168 Lupus Nephritis Trial

The regulatory green light arrives under the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, highlighting the urgent clinical demand for new approaches to treating severe systemic inflammation. C-CAR168 functions by targeting both CD20 and BCMA, aiming to deplete disease-driving B cells and plasma cells to trigger an immune system reset. This mechanism is intended to address the persistent disease activity and kidney damage risks that often plague patients refractory to current immunosuppressive regimens.

Tony (Bizuo) Liu, Chairman and CEO of AbelZeta, described the clearance as a critical progression for a modality that has already secured RMAT and PRIME designations from U.S. and European regulators. Beyond the immediate focus on Lupus Nephritis, the company is actively investigating the potential of C-CAR168 for other autoimmune indications, including progressive Multiple Sclerosis. The firm continues to develop its pipeline of cell-based therapies through its GMP facilities located in Rockville, Maryland, and Shanghai.