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Orphan drug designation granted to MB-105 for the treatment of R/R T-cell lymphoma
On January 29, 2025, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to MB-105, a first-in-class autologous CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory (R/R) T-cell lymphoma.1
This announcement is based on key results from a phase I MB-105 (NCT03081910) trial, which demonstrated favorable safety/tolerability and promising clinical efficacy of MB-105 in patients with R/R T-cell lymphoma (N = 17), with an overall response rate of 44%.1,2
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