CD5-Targeting CAR T-Cell Therapy Receives FDA Orphan Drug Designation for T-Cell Lymphoma Use

The FDA has granted orphan drug designation to MB-105, a first-in-class autologous CD5-targeting chimeric antigen receptor (CAR) T-cell therapy, for use in relapsed or refractory T-cell lymphoma. The new designation was announced in a press release from March Biosciences, Inc, a clinical stage biotechnology company the developer of this new CAR T-cell therapy.

“Beyond an important regulatory milestone, securing orphan drug designation for MB-105 from the FDA underscores the critical need for new therapeutic options for patients with T-cell lymphoma,” commented March Biosciences co-founder and chief executive officer Sarah Hein, PhD, in the release.

MB-105 is the lead program for March Biosciences and was launched by the company from the Center for Cell and Gene Therapy, Houston, Texas. Work at the Center on this treatment is a collaboration of Baylor College of Medicine, Houston Methodist Hospital, and Texas Children’s Hospital, each located in Houston, Texas.

This new CAR T-cell therapy is being developed for management of CD5-positive T-cell lymphomas, as well as CD5-positive T-cell acute lymphoblastic leukemias, chronic lymphocytic leukemias, and mantle cell lymphomas. It is distinguished by a proprietary CAR design that enables the treatment to preserve certain normal T-cell functions while it targets malignant cells.

MB-105 is currently being evaluated in a phase 1 clinical trial for relapsed or refractory T-cell lymphoma and T-cell acute lymphoblastic leukemia. Among patients with T-cell lymphoma in the trial, the therapy has produced a 44% overall response rate.

“The MB-105 Phase 1 trial has shown promising safety and efficacy signals in relapsed / refractory T-cell lymphoma patients. This designation further validates our development strategy as we prepare to initiate our Phase 2 clinical trial in early 2025,” Dr. Hein explained.

Reference

March Biosciences receives FDA orphan drug designation for MB-105, a first-in-class CD5 CAR-T cell therapy, for T-cell lymphoma. Press release. GlobeNewswire. January 28, 2025. Accessed January 30, 2025.