NEW YORK – Mustang Bio said on Monday that the US Food and Drug Administration has accepted its investigational new drug application for MB-106 as a treatment for patients with certain blood cancers, allowing the firm to begin evaluating the treatment in clinical trials during the third quarter of this year.
MB-106 is an autologous CAR T-cell therapy that Mustang is developing as a treatment for patients with relapsed or refractory, CD20-positive, B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. In the upcoming Phase I/II clinical trial, the Worcester, Massachusetts-headquartered company will evaluate the treatment's safety, tolerability, and efficacy.
The autologous therapy was originally developed at the Fred Hutchinson Cancer Research Center and exclusively licensed to Mustang in 2017. Mustang is also evaluating an IL13Rα2-directed CAR T-cell therapy, MB-101, in a Phase I clinical trial for brain cancer patients, as well as a CD123-targeted CAR T cell therapy, MB-102, as a treatment for patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia, and high-risk myelodysplastic syndrome (hrMDS).