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

NCT07386002 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Interventions

BIOLOGICAL

Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3

MT027 will be injected intracerebroventricularly at a dose of 3×10\^7 cells on Day 1 \& Day 15 of each 28-day treatment cycle.

Sponsors & Collaborators

  • Virginia Contract Research Organization Co., Ltd.

    collaborator OTHER

  • T-MAXIMUM Pharmaceutical Inc

    lead INDUSTRY

Principal Investigators

  • Solmaz Sahebjam, MD · The Johns Hopkins Cancer Center, Sibley Memorial Hospital

  • Kuo-Chen Wei, MD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-12-13
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386002 on ClinicalTrials.gov