AbelZeta Receives FDA IND Clearance for Phase 1b/2 Clinical Trial of C-CAR168 in Progressive Multiple Sclerosis
AbelZeta Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for C-CAR168, an anti-CD20/BCMA bispecific CAR-T therapy. This clearance allows the company to initiate a Phase 1b/2 clinical trial focusing on patients with progressive multiple sclerosis who are refractory to standard therapy.
The IND clearance expands AbelZeta's clinical program for C-CAR168 into treating refractory chronic autoimmune neurological diseases. This follows two recent regulatory milestones for C-CAR168 concerning refractory systemic lupus erythematosus, including the FDA’s clearance of a multicenter registrational Phase II clinical trial and the PRIority MEdicines designation from the European Medicines Agency.
“The FDA clearance of this Phase 1b/2 study represents another important step in realizing the potential of C-CAR168 across refractory chronic autoimmune diseases,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. He noted the significant unmet medical need for therapies addressing the immune dysfunction driving disease progression in progressive multiple sclerosis, a condition that can lead to irreversible neurological disability.
The multi-center, Phase 1b/2 clinical study will evaluate the safety, tolerability, and efficacy of C-CAR168 in patients with progressive multiple sclerosis who have not responded adequately to standard therapies. Approximately 6 to 24 patients will be enrolled in Phase 1b to determine the recommended Phase 2 dose, while the Phase 2 portion will involve about 95 patients in two cohorts.
C-CAR168 aims to induce an immune reset in patients by targeting disease-driving B cells and plasma cells, and is being assessed across various autoimmune diseases, including systemic sclerosis and systemic lupus erythematosus. Early efficacy signals from a Phase 1 first-in-human trial indicated improvements in patients with secondary progressive multiple sclerosis.
AbelZeta Pharma, Inc. is a global clinical-stage biopharmaceutical company based in Rockville, Maryland, and Shanghai, focusing on innovative cell-based therapeutic products. The company is committed to developing treatments that utilize the body's immune system against hematological malignancies and autoimmune diseases.