March Biosciences’ MB-105 CAR-T Therapy Receives FDA RMAT Designation For Relapsed Or Refractory CD5-Positive T-Cell Lymphoma

March Biosciences (March Bio), a clinical-stage biotechnology company developing cell therapies for hard-to-treat cancers, announced that the U.S. 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. MB-105 is being developed for patients with relapsed or refractory CD5-positive T-cell lymphoma, a population with a significant unmet medical need.

The RMAT designation was awarded based on data from March Bio’s ongoing multi-center Phase 2 clinical trial (NCT06534060). Preliminary findings from the safety run-in cohort show early signs of clinical activity and a manageable safety profile. Initial results from this cohort will be presented at the American Society of Hematology (ASH) 2025 Annual Meeting, with further updates expected in 2026. The company plans to engage with the FDA to outline next steps for an expedited development and review pathway for MB-105.

RMAT designation is designed to accelerate the development and review of regenerative medicine therapies for serious or life-threatening conditions when early clinical evidence suggests potential to address unmet medical needs. The designation includes the benefits of the FDA’s Breakthrough Therapy and Fast Track programs, such as more frequent interactions with the agency and eligibility for expedited review mechanisms including rolling and priority review.

Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences, commented on the announcement, stating, “The FDA’s RMAT designation further validates MB-105’s potential to address a critical unmet medical need for patients with relapsed or refractory T-cell lymphoma, who face a median survival of only six months with current therapies. We are encouraged by the responses observed to date and look forward to working closely with the FDA to advance MB-105 as efficiently as possible.”

In addition to U.S. development, March Bio intends to explore clinical and commercial opportunities internationally and engage with regulators in other markets to define the most efficient path forward as additional data become available. This designation marks an important milestone in advancing MB-105 toward providing a potentially transformative therapy for patients with limited treatment options in T-cell lymphoma.