The FDA has cleared Beijing-based T-MAXIMUM PHARMACEUTICAL to initiate a phase 2 clinical study of the company’s allogeneic CAR-T cell therapy, MT027, for the treatment of patients with brain metastases from lung cancer and breast cancer.
MT027 is an investigational, B7-H3-targeted universal (allogeneic) CAR-T cell therapy developed using a fully non-viral gene-editing process and administered via local intracranial delivery.
Brain metastases commonly arise in patients with lung cancer, breast cancer, melanoma, renal cell carcinoma, and colorectal cancer. International studies estimate that approximately 20% of cancer patients may develop brain metastases over the course of their disease. These metastases can be accompanied by headaches, seizures and cognitive and motor impairment.
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 and fast track designation.
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