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The GLIOMAX Study: MT027 for Recurrent Glioblastoma

This Phase II study, called GLIOMAX, is testing a treatment called MT027 for people aged 18 to 70 with recurrent (returned) or progressive (worsening) glioblastoma (a type of brain cancer) that has a specific genetic makeup (IDH-wildtype). You would have already received standard treatments for your cancer. MT027 is a type of cell therapy (CAR-T) that will be injected directly into the fluid around your brain (intracerebroventricularly). The study aims to see how safe MT027 is, how well your body tolerates it, and how effective it is at treating the cancer. Researchers will also look at how long people live after treatment. The study plans to enroll 40 participants.

Study design
This is a Phase II interventional study, meaning all participants will receive the MT027 treatment. It plans to enroll 40 participants.
What's involved
You would undergo screening, receive MT027 injections on Day 1 and Day 15 of each 28-day cycle, and have safety and long-term follow-up appointments. Treatment continues until unacceptable side effects or disease progression.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety after treatment, and then for up to 12 months to measure overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07386002

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

Not Yet Recruiting
PHASE2Ages 18–70InterventionalTreatment
T-MAXIMUM Pharmaceutical Inc
~40 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence rate of Dose-limiting toxicity (DLT)
Measured over From the first dose to 2 weeks after the second dose
+1 more outcome measured

Conditions

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Explore related trials

GlioblastomaCD276 wt AlleleIDH1 wt Allele

Where it's being run

4 sites across 2 states
Taiwan3
Maryland1

Study leadership

  • Solmaz Sahebjam, MD · STUDY_CHAIR · The Johns Hopkins Cancer Center, Sibley Memorial Hospital
  • Kuo-Chen Wei, MD · PRINCIPAL_INVESTIGATOR · Chang Gung Memorial Hospital

Who to contact

Dan Wang, MD
[email protected]
+1-916-214-2608
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

According to the histological/molecular pathology, diagnosed with GBM WHO grade 4
According to the histopathology or radiological imaging, confirmed disease progression or recurrence
First recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ), or first recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ) and received Bevacizumab treatment 4. Participants with either unresectable lesions, or with resectable lesions who have undergone prior surgical resection, or with resectable lesions and no planned reoperation within 3 months after enrollment based on Investigator's judgment 5. Participants voluntarily provide the latest archival tumor or fresh biopsies FFPE samples (at least 8 consecutive non-stained sections) for B7H3 expression test by Immunohistochemistry (IHC), and the clinical pathology confirms positive B7H3 expression, defined as the proportion of 2+ and 3+ ≥ 20% (Reference refer to Appendix 13.1) or historical B7H3 positive expression within 12 months at the time of enrollment 6. Karnofsky Performance Status (KPS) score ≥ 60 7. Life expectancy of ≥ 12 weeks 8. Adequate organ and marrow functions as defined below: (blood transfusion, blood component transfusion, or hematopoietic stimulating factors within 7 days prior to the first dose is not allowed)
Female patients of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication
Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately

What this trial measures

  • Incidence rate of Dose-limiting toxicity (DLT)From the first dose to 2 weeks after the second dose

    Incidence rate of Dose-limiting toxicity (DLT) after treatment in the safety run-in stage

  • 12-month overall survival (OS) rateFrom the first dose to 12 months after the treatment