March Biosciences wins FDA RMAT designation for MB-105

Texas, USA-based clinical-stage biotech March Biosciences announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-105, the company’s first-in-class autologous CD5-targeted CAR-T cell therapy, in development for relapsed/refractory CD5-positive T-cell lymphoma.

The RMAT designation was granted based on data from March Bio’s ongoing multicenter Phase II clinical trial (NCT06534060). Preliminary findings from the safety run-in cohort suggest evidence of clinical activity with a manageable safety profile in a patient population with a significant unmet medical need. Initial results from this cohort will be presented at the American Society of Hematology 2025 Annual Meeting, with additional updates anticipated in 2026. 

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