AbelZeta Receives FDA Clearance of Registrational Phase II Trial for C-CAR168 in Refractory Lupus Nephritis
AbelZeta Pharma, Inc., a global clinical-stage biopharmaceutical company, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation for a multiple-center registrational Phase II clinical trial of C-CAR168, an anti-CD20/BCMA bispecific CAR-T. This trial will evaluate the treatment of patients with Lupus Nephritis (LN) who are refractory to standard therapy, addressing a significant unmet medical need.
Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta, stated, "The FDA clearance to proceed with this multiple-center registrational Phase II trial for C-CAR168 in LN represents an important step forward in the development of this promising new modality for patients with severe, treatment-refractory lupus.” Liu highlighted the regulatory advancements, mentioning the RMAT and PRIority MEdicines (PRIME) designations granted by the FDA and European Medicines Agency (EMA), respectively, as indicators of C-CAR168's potential to impact autoimmune diseases.
C-CAR168 is described as a novel autologous bi-specific CAR-T therapy that targets both CD20 and BCMA, aiming to induce an immune reset in patients suffering from severe autoimmune diseases, including refractory Systemic Lupus Erythematosus (SLE) and Lupus Nephritis. The drug has received both RMAT and PRIME designations for the treatment of refractory SLE, including LN.
Systemic Lupus Erythematosus is noted as a chronic autoimmune disease leading to systemic inflammation and multi-organ involvement, with Lupus Nephritis specifically affecting the kidneys and potentially resulting in kidney failure. Patients experiencing refractory disease often face significant challenges related to persistent symptoms and complications from long-term immunosuppressive treatment.
AbelZeta Pharma is focused on developing innovative cell-based therapeutic products, with facilities in Rockville, Maryland, and Shanghai. The company aims to create personalized treatments leveraging the immune system to combat hematological malignancies and various autoimmune and inflammatory diseases, maintaining a pipeline that includes multiple CAR-T therapies.