AbelZeta gets FDA IND clearance for bispecific CAR-T therapy in MS

The U.S. FDA has cleared AbelZeta Pharma’s IND to initiate a phase 1b/2 clinical trial evaluating C-CAR168, an anti-CD20/BCMA bispecific CAR-T, in patients with progressive multiple sclerosis refractory to standard therapy.

This IND clearance expands AbelZeta's C-CAR168 clinical development program into refractory chronic autoimmune neurological disease. The therapy also has FDA RMAT designation for a phase 2 trial in refractory systemic lupus erythematosus and a PRIME designation from the EMA.

C-CAR168 is a novel autologous bispecific CAR-T therapy targeting CD20 and BCMA. It is designed to achieve deep depletion of disease-driving B-cells and plasma cells, with the goal of inducing an immune reset in patients with severe autoimmune diseases.

Back in August, AbelZeta got FDA clearance of its IND application for the company's anti-CD20/CD19 bispecific CAR-T, prizlon-cel, for the treatment of relapsed or refractory large B-cell lymphoma shortly after J&J had handed back the rights to the therapy.