March Biosciences Receives FDA RMAT Designation for CAR-T Therapy Targeting Aggressive T-Cell Lymphoma
The FDA granted RMAT designation to March Biosciences' MB-105 CAR-T therapy for relapsed T-cell lymphoma, potentially accelerating treatment development for patients with limited survival options.
The U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to March Biosciences' MB-105, an autologous CD5-targeted CAR-T cell therapy for relapsed or refractory CD5-positive T-cell lymphoma. This regulatory milestone could significantly accelerate development of a treatment for patients who currently face a median survival of only six months with existing therapies.
The RMAT designation was awarded based on data from March Biosciences' ongoing multicenter Phase 2 clinical trial (NCT06534060). Preliminary findings from the safety run-in cohort indicate evidence of clinical activity with a manageable safety profile in a patient population with 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.
Established to expedite development and review of regenerative medicine therapies for serious or life-threatening diseases, RMAT designation provides all the benefits of the FDA's Breakthrough Therapy and Fast Track programs. This includes enhanced and frequent interactions with the regulatory agency throughout development and eligibility for expedited review mechanisms such as rolling and priority review. The company plans to engage with the FDA on next steps to support an expedited development pathway for MB-105.
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 a critical unmet medical need. The company is encouraged by the responses observed to date and looks forward to working closely with the FDA to advance MB-105 as efficiently as possible. March Biosciences will also explore clinical and commercial development outside the United States and engage with international regulators as data mature.
MB-105 represents 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. The multicenter Phase 2 trial is currently enrolling patients at twelve sites across the United States. More information about the company's research can be found at https://www.march.bio.