Clinical-stage biopharmaceutical company AbelZeta Pharma Inc announced on Monday the receipt of US Food and Drug Administration (FDA) clearance under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding the multiple-centre registrational Phase II clinical trial for C-CAR168, an anti-CD20/BCMA bispecific CAR-T, in the treatment of patients with Lupus Nephritis (LN) refractory to standard therapy.

The Phase II trial will further evaluate the safety and efficacy of C-CAR168 in this patient population with significant unmet medical needs.

C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and BCMA. C-CAR168 is designed to support deep depletion of disease-driving B cells and plasma cells, with the goal of inducing an immune reset in patients with severe autoimmune diseases, including refractory Systemic Lupus Erythematosus (SLE) and LN, and progressive Multiple Sclerosis (MS).

The FDA and the EMA have granted RMAT and PRIME designations, respectively, to C-CAR168 for the treatment of refractory SLE including LN.