March Bio doses first T-cell lymphoma patient with CD5 CAR-T

March Biosciences has dosed its first patient in a phase 2 trial evaluating its first-in-class CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

MB-105 is an autologous CD5-targeted CAR-T cell therapy that employs a proprietary CAR design that enables selective targeting of malignant cells while preserving normal T-cell function. It is orphan-drug designated and in development for CD5-positive hematologic malignancies, including T-cell lymphoma, T-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, and mantle cell lymphoma.

The phase 2 trial is a multi-center, single-arm, two-stage, open-label study that will enroll approximately 46 patients across both stages. The trial will be conducted at leading cancer centers across the U.S., with the first patient dosed at the University of Texas MD Anderson Cancer Center.

The phase 2 trial builds on promising phase 1 results where the therapy demonstrated both a favorable safety profile and durable remissions in heavily pretreated patients with relapsed/refractory T-cell lymphoma.

“CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts,” said Sarah Hein, co-founder and CEO at March Bio.