FDA Grants Orphan Drug Designation to CD5-Targeting CAR T-Cell Therapy for T-Cell Lymphoma

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

“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,” remarked March Biosciences co-founder and chief executive officer Sarah Hein, PhD, in the release.

This new CAR T-cell therapy is the lead program for March Biosciences and was launched by the company from the Center for Cell and Gene Therapy, Houston, Texas. The ongoing work at the Center on this therapy is a collaboration between Baylor College of Medicine, Houston Methodist Hospital, and Texas Children’s Hospital, each located in Houston, Texas.

MB-105 is in development for management of CD5-positive T-cell lymphomas, along with CD5-positive T-cell acute lymphoblastic leukemias, chronic lymphocytic leukemias, and mantle cell lymphomas. The therapy features a proprietary CAR design that enables it to preserve certain normal T-cell functions as it targets malignant cells.

A phase 1 clinical trial is underway to evaluate MB-105 for relapsed or refractory T-cell lymphoma and T-cell acute lymphoblastic leukemia. The therapy has resulted in a 44% overall response rate for patients with T-cell lymphoma in the trial.

“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 elaborated.

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.