FDA Brief: New Drug Application Accepted for CD20-Targeted CAR T-Cell Therapy for CLL
Posted: Monday, May 17, 2021
On May 10, Mustang Bio announced that the U.S. Food and Drug Administration (FDA) accepted an investigational new drug application to start a phase I/II multicenter clinical trial to investigate MB-106. This new agent is a CD20-targeted chimeric antigen receptor (CAR) T-cell therapy for relapsed or refractory CD20-positive chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin lymphoma.
MB-106 is currently being studied in an ongoing phase I/II study, where it has shown a reportedly favorable safety profile, with an 89% overall response rate and a 44% complete response rate.
The new multicenter study will be studying the safety, tolerability, and efficacy of MB-106. The enrollment period is expected to begin in the third quarter of this year.
