The US Food and Drug Administration (FDA) has cleared T-Maximum to initiate a phase 2 clinical study of MT027, its internally-developed, B7-H3-targeted universal (allogeneic) CAR-T therapy, for the treatment of patients with brain metastases from lung cancer and breast cancer.
This is the second phase 2 study of MT027 to receive FDA clearance. MT027 was previously cleared by the FDA to proceed with a phase 2 study in recurrent glioblastoma, and has been granted orphan drug designation (ODD) and fast track designation (FTD). With two FDA-cleared phase 2 programmes, T-Maximum has established a dual-indication portfolio for universal CAR-T therapy covering both primary and metastatic intracranial solid tumours.
