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 or refractory CD5-positive T-cell lymphoma. This regulatory milestone represents a significant advancement for patients facing this aggressive cancer who currently have limited treatment options and 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 suggest evidence of clinical activity with a manageable safety profile in this patient population with substantial 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 the development and review of regenerative medicine therapies for serious or life-threatening diseases, the 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 and review pathway for MB-105.

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 at twelve sites across the United States.

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. March Biosciences will explore clinical and commercial development outside the United States and engage with international regulators to define the most efficient path forward as additional data mature. The company maintains an online presence at https://www.march.bio where stakeholders can follow development progress.

This regulatory advancement comes at a critical time for T-cell lymphoma patients, particularly those who have exhausted conventional treatment options. The RMAT designation not only validates the potential clinical benefit observed in early studies but also signals the FDA's recognition of the urgent need for effective therapies in this challenging disease area. As cell therapies continue to transform cancer treatment, MB-105's progress represents an important step forward in addressing cancers that have proven resistant to current immunotherapeutic approaches.