March Bio wins RMAT tag for T-cell lymphoma CAR-T

The U.S. FDA has granted regenerative medicine advanced therapy (RMAT) designation to March Biosciences’ 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 multi-center phase 2 clinical trial for MB-105. 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 will be presented at the American Society of Hematology 2025 Annual Meeting, with additional updates anticipated in 2026.

MB-105 has also received orphan drug designation for the treatment of relapsed/refractory CD5-positive TCL. March Bio plans to engage with the FDA on next steps to support an expedited development and review pathway for MB-105.

MB-105 is in development for CD5-positive hematologic malignancies, including T-cell lymphoma, T-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, and mantle cell lymphoma. The therapy employs a proprietary CAR design that enables selective targeting of malignant cells and streamlined manufacturing without additional genetic manipulation.