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FDA clears investigational new drug application for CD20-directed CAR T-cell therapy MB-106
By Claire Baker
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On May 10, 2021, it was announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application to evaluate MB-106 for relapsed or refractory (R/R) CD20+ B-cell malignancies.
This decision allows the initiation of a phase I/II multicenter study that will investigate the safety, tolerability, and efficacy of MB-106 in patients with R/R B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia (CLL). The study is due to begin by the end of 2021.
MB-106 is a CD20-directed, autologous chimeric antigen receptor (CAR) T-cell therapy designed to express a third-generation CAR, that was created at the Fred Hutchinson Cancer Research Center.
- Mustang Bio. Mustang Bio announces FDA acceptance of IND application for MB-106, a CD20-targeted CAR T therapy. https://ir.mustangbio.com/News/news-details/2021/Mustang-Bio-Announces-FDA-Acceptance-of-IND-Application-for-MB-106-a-CD20-Targeted-CAR-T-Therapy/default.aspx. Published May 10, 2021. Accessed May 13, 2021.
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