FDA grants Orphan Drug designation to CD5-targeted CAR-T cell therapy for T-cell lymphoma

The US Food and Drug Administration (FDA) granted Orphan Drug designation to MB-105, a CD5-targeted chimeric antigen receptor (CAR)-T cell therapy, for the treatment of relapsed or refractory CD5-positive T-cell lymphoma.

MB-105 is a first-in-class autologous CD5-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia, and mantle cell lymphoma.

The therapy employs a proprietary CAR design that enables selective targeting of malignant cells while preserving some normal T-cell function, according to the drug manufacturer, March Biosciences.

MB-105 is currently being evaluated in a phase 1 clinical trial for relapsed or refractory TCL and T-ALL, demonstrating a 44% overall response rate in TCL patients.

“Currently, patients with treatment-resistant or recurrent T-cell cancers face an extremely poor prognosis,” said Sarah Hein, co-founder and CEO of March Biosciences, who submitted the application, in a press release. “The MB-105 phase 1 trial has shown promising safety and efficacy signals in relapsed/refractory T-cell lymphoma patients.”