March Biosciences Receives FDA RMAT Designation for MB-105 CAR-T Therapy in T-Cell Lymphoma

The U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to MB-105, March Biosciences' first-in-class autologous CD5-targeted CAR-T cell therapy for relapsed/refractory CD5-positive T-cell lymphoma. This regulatory milestone is significant because it could accelerate development of a treatment for patients who currently face a median survival of only six months with existing therapies, representing a critical unmet medical need in oncology.

The RMAT designation was awarded based on data from March Biosciences' ongoing multi-center Phase 2 clinical trial (NCT06534060), with preliminary findings from the safety run-in cohort suggesting evidence of clinical activity with a manageable safety profile. Initial results from this cohort will be presented at the American Society of Hematology 2025 Annual Meeting, with additional updates anticipated in 2026. The company plans to engage with the FDA on next steps to support an expedited development and review pathway for MB-105.

RMAT designation was established specifically to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases where early clinical evidence indicates potential to address unmet medical needs. The designation provides all the benefits of the FDA's Breakthrough Therapy and Fast Track programs, including enhanced and frequent interactions with the Agency throughout development and eligibility for expedited review mechanisms such as rolling and priority review. This regulatory pathway could significantly shorten the time to potential approval and patient access.

Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences, stated that the FDA's RMAT designation further validates MB-105's potential to address this critical unmet medical need. The company will also explore clinical and commercial development outside the United States and engage with regulators to define the most efficient path forward as data mature. MB-105 represents a novel approach as a potential first-in-class autologous CD5-targeted CAR-T cell therapy 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. Beyond the RMAT designation, MB-105 has also received Orphan Drug Designation from the FDA for the treatment of relapsed/refractory CD5-positive T-cell lymphoma. The multicenter Phase 2 trial is currently enrolling at twelve sites across the United States, with additional information available at https://www.march.bio. This development marks an important advancement in the field of cell therapies for hard-to-treat cancers, particularly for T-cell malignancies that have historically been challenging to treat with conventional approaches.