The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma (NCT07386002) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma
United States, Taiwan40 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent must be obtained prior to any procedures that are not considered SOC
. ≥ 18 years old and ≤ 70 years old on the day of signing informed consent, male or female
. According to the WHO Classification of Tumors of the CNS (2021), definitely diagnosed recurrent or progressive GBM, WHO Grade 4, which must meet all 3 of the following criteria:
. 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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an allogeneic CAR-T therapy, meaning the immune cells come from a donor rather than the patient themselves — can you explain how that approach might affect my immune response or the risk of rejection compared to other CAR-T options?
2Since the trial is in Phase 2 and is not yet recruiting, what does that mean for how soon I might realistically be able to access it, and should I be pursuing other treatments in the meantime?
3One of the main things this study is measuring is dose-limiting toxicity — what kinds of serious side effects are they watching for with this type of CAR-T therapy in glioblastoma, and how would those be managed if they occurred?
4The trial is specifically for IDH wildtype glioblastoma that has come back after prior treatment — given my specific situation, is this the right disease profile and timing for me to even consider discussing enrollment when the study opens?
5The trial is tracking 12-month overall survival as a key outcome — based on what's known so far about allogeneic CAR-T in recurrent glioblastoma, how does this approach compare to standard salvage options you might recommend for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence rate of Dose-limiting toxicity (DLT)
Timeframe: From the first dose to 2 weeks after the second dose
2
12-month overall survival (OS) rate
Timeframe: From the first dose to 12 months after the treatment
. 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)
Exclusion criteria
. Brainstem and thalamus recurrence, spinal cord dissemination or extracranial metastasis
. The largest diameter of a single tumor lesion \> 5 cm, or the sum of the largest diameters of multiple lesions \> 6 cm
. Symptoms and signs of chronic intracranial hypertension that are difficult to control with drugs (such as daily use of Mannitol \> 500 mL or Dexamethasone \> 15 mg or Methylprednisolone \> 80 mg or other hormones at the same dose)
. Uncontrolled seizure or epilepsy aggravation requiring escalation of antiepileptic therapy over the last 4 weeks
. Participated in other therapeutic clinical trials within 4 weeks prior to screening
. Previously received other allogeneic tissue/solid organ transplantation OR other CAR-T cell therapy
. Previously received Carmustine wafer, oncolytic viruses or other intratumoral implants treatment (e.g., GLIADEL® Wafer)
. Prior history of severe allergy to any component or biological product of the investigational drug