AbelZeta Pharma, a clinical-stage biopharmaceutical company with operations in Rockville, Maryland and Shanghai, China, announced receipt of PRIority MEdicines (PRIME) designation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for C-CAR168, an autologous bi-specific CAR-T cell therapy, for refractory systemic lupus erythematosus with or without lupus nephritis. The designation is among the first instances of a CAR-T cell therapy receiving this level of EMA regulatory recognition in a lupus indication, following an RMAT designation from the US FDA granted for the same population in May 2025.
PRIME provides earlier and more frequent scientific advice from the EMA and may support accelerated assessment of a future marketing application. Unlike the US FDA’s RMAT designation, it does not include rolling review but enables earlier regulatory engagement that can help shape pivotal trial design.
C-CAR168 uses a dual CD20/BCMA-targeting construct designed to deplete both autoreactive B cells and the antibody-producing plasma cells that continue to generate pathogenic autoantibodies after B-cell-only depletion. Targeting BCMA alongside CD20 is intended to reach plasma cells that lack CD20 expression, a population thought to sustain disease activity following single-target B-cell depletion approaches such as rituximab or CD19 CAR-T constructs.