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MB-105 granted FDA RMAT designation for R/R CD5+ T-cell lymphoma
On November 11, 2025, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to MB-105, a first-in-class autologous CD5-targeted CAR T-cell therapy.1 This designation is for the treatment of patients with CD5-positive relapsed/refractory (R/R) T-cell lymphoma, a patient population with a significant unmet medical need.1 The FDA previously granted MB-105 orphan drug designation.
The RMAT designation was based on results from an ongoing multicenter, phase II trial (NCT06534060).1 Preliminary results suggest clinical activity with a manageable safety profile.1 Results from an interim analysis of this trial will be presented at the upcoming 67th American Society of Hematology (ASH) Meeting and Exposition, Dec 6–9, 2025, Orlando, US.
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In your experience, does lisocabtagene maraleucel offer a durable, potentially curative remission with a one-time infusion in second-line large B-cell lymphoma?
