Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors

This study adopted a single-arm, open-label, single-center clinical trial design. The study population consisted of patients with high-grade glioma, aged 18 - 70 years old, whose B7H3 antigen expression was positive and had been confirmed by histology or cytology, and who had recurrence or progression after standard treatment. Subjects received local injection administration (intraventricular administration via an Ommaya reservoir or intrathecal administration into the lumbar cistern through lumbar puncture). For intrathecal injection via lumbar puncture, the dosage for each administration was divided into four dose levels: 1.0, 1.5, 2, 2.5 × 10⁷ cells per time, and the administration frequency was once every 4 weeks. During the study period, adverse events were observed and recorded, with special attention paid to product-specific adverse reactions such as graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). Cerebrospinal fluid (CSF) and blood samples were collected to analyze PK and PD indicators such as CAR copy numbers and cytokines in the samples. Efficacy evaluations were conducted once per cycle, and efficacy indicators such as overall survival (OS), 12-month overall survival rate (12m-OS), objective response rate (ORR), and disease control rate (DCR) were calculated.