Clinical Trial

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

Study acronym: GLIOMAX-101
Not Yet Recruiting Phase 2
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Summary
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. Each participant will undergo screening, treatment (receiving MT027 at a dose of 3×10\^7 cells), safety follow-up, and long-term follow-up periods. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle. If the participant does not experience any unacceptable toxicities and disease progress in the first cycle, 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. 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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-27; most recent amendment 2026-02-06.
Trial Details
NCT Number NCT07386002
Lead Sponsor T-MAXIMUM Pharmaceutical Inc
Collaborators: Virginia Contract Research Organization Co., Ltd.
Conditions Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Enrollment 40 participants
Start Date 2026-06-30
Primary Completion 2028-12-13 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-10