Posted by Michael Wonder on 13 Jan 2022
CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma
12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens, both regenerative medicine advanced therapy designation and fast track designation for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma.
Early clinical results of C-CAR039 from an investigator-initiated trial (IIT) conducted across multiple sites in China demonstrate exciting efficacy and favourable safety data of C-CAR039 in relapsed or refractory diffuse large B cell lymphoma.
