The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma

This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.

The study will begin with a safety run-in of 3 to 6 participants to evaluate the safety and tolerability of MT027 at a dose of 3×10\^7 cells. Once the DLT assessment is complete, an additional 34 participants will be enrolled, bringing the total to 40, to evaluate the treatment's efficacy. Each participant will undergo screening, treatment, safety follow-up, and long-term follow-up periods. Any participant who has discontinued from study treatment other than disease progression will also continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, withdrawal from the study, or death, whichever comes first. Upon completion of the safety follow-up, all patients, except those who died, withdrew consent, or were lost to follow-up, will enter to the long-term follow-up. It is regarded as the end of the study when the last participant has completed the 1-year long-term follow-up, or all participants have progressed, died, or lost to follow-up, whichever comes first. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle, and the DLT observation period will be 28 days following the first dose of the first cycle (only for safety run-in group). After the DLT observation period, if the participant does not experience any unacceptable toxicities and disease progress, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. When confirming disease progression, the study treatment may still be continued if there's a potential for benefit, based on PI's discretion and the participant's willingness, particularly when there are no better treatment options available. Investigational product (IP) may be temporarily interrupted to allow safety management and will resume the study treatment dose after participant's adverse events are recovered to the Grade 1 level or baseline, per PI's discretion. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.