T-MAXIMUM allogeneic CAR-T gets FDA fast track in glioblastoma

The U.S. FDA has granted Beijing-based-T-MAXIMUM PHARMACEUTICAL’s allogeneic CAR-T cell therapy, MT027, fast track designation for the treatment of recurrent glioblastoma.

MT027 is differentiated by the combination of three elements — B7-H3 targeting, an allogeneic "off-the-shelf" product format, and a locoregional intracavitary route of administration — directed at recurrent glioblastoma, a fast-growing, aggressive brain tumor.

In addition to recurrent glioblastoma, the company is also exploring the potential of MT027 in brain metastases and in other solid tumor settings suited to local delivery.

MT027 had previously received FDA orphan drug designation for the treatment of recurrent high-grade glioma, and clearance from the FDA to conduct a phase 2 clinical study in recurrent glioblastoma.