March Biosciences Receives FDA RMAT Designation for MB-105 in Relapsed/Refractory CD5-Positive T-Cell Lymphoma
Wednesday, November 12, 2025
March Biosciences has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its lead candidate, MB-105.
MB-105 is a first-in-class autologous CD5-targeted CAR-T cell therapy being investigated for CD5-positive haematologic cancers, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukaemia (T-ALL), chronic lymphocytic leukaemia (CLL), and mantle cell lymphoma (MCL). The therapy uses a proprietary CAR design that enables selective targeting of malignant cells and simplified manufacturing without additional genetic modification. MB-105 has been granted both Orphan Drug Designation and RMAT designation by the FDA for the treatment of relapsed or refractory CD5-positive TCL. The ongoing multicentre Phase 2 study is enrolling patients across twelve sites in the United States.
The therapy is being developed as an autologous CD5-targeted CAR-T cell treatment for patients with relapsed or refractory CD5-positive T-cell lymphoma.
The RMAT designation was granted based on data from an ongoing multi-centre Phase 2 clinical trial (NCT06534060). Early findings from the safety run-in cohort have shown evidence of clinical activity and a manageable safety profile in patients with limited treatment options. Initial results from the study are expected to be presented at the American Society of Hematology 2025 Annual Meeting, with further updates anticipated in 2026.
This designation aims to accelerate the development and review of regenerative medicine therapies for serious or life-threatening conditions where early clinical evidence suggests potential to address unmet medical needs. It provides benefits similar to the FDA’s Breakthrough Therapy and Fast Track programmes, including frequent interactions with the agency and eligibility for expedited review pathways such as rolling and priority review.
The designation recognises MB-105’s potential to address a critical need among patients with relapsed or refractory T-cell lymphoma, a condition with poor prognosis and limited treatment options.
March Biosciences plans to collaborate with the FDA to advance the programme and explore clinical and commercial opportunities beyond the United States as data continue to develop.
Source: globenewswire.com
