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

NCT07386002 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MT027-GBM-101
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Recurrent or Progressive Glioblastoma; MT027

Outcome Measures

Primary Outcomes (2)

• Incidence rate of Dose-limiting toxicity (DLT)

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

  From the first dose to 2 weeks after the second dose

• 12-month overall survival (OS) rate

  From the first dose to 12 months after the treatment

Study Arms (1)

MT027

EXPERIMENTAL

Intracerebroventricular administration of MT027 (3×10\^7 B7-H3 Targeted UCAR-T-cell)

Biological: Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3

Interventions

Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3 BIOLOGICAL

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

MT027

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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
• Karnofsky Performance Status (KPS) score ≥ 60
• Life expectancy of ≥ 12 weeks
• 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)
• Hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, and hemoglobin ≥ 90 g/L
• Hepatic: ALT and AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN
• Renal: Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated Cr clearance ≥ 30.0 mL/min using Cockcroft-Gault formula
• Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participant is receiving anticoagulant therapy in which case the APTT and INR must be within the therapeutic range of intended use for the anticoagulant)

You may not qualify if:

• A patient meeting any of the following criteria is not eligible to participate in this study (applied to all patients screened in safety run-in and dose expansion stages, unless specified):
• 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
• History of other malignancy within 5 years of screening with the following exceptions: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) carcinoma in situ of the breast, d) local prostate cancer after radical resection and/ or definitive RT with stable prostate specific antigen (PSA) levels for 1 year
• Serious diseases such as active systemic infection, coagulation dysfunction, history of interstitial lung disease, radiation pneumonitis, or evidence of active pneumonia that is not considered appropriate by Investigator
• Clinically significant uncontrolled heart, lung, liver, renal and neuro insufficiency including Class III or above heart failure according to the New York Heart Association (NYHA) standard, Stage IV liver cirrhosis; chronic kidney disease (CKD) Stage III or above; Symptoms of severe respiratory failure involving other organs; Uncontrolled seizure activity and/or clinically evident progressive encephalopathy
• History or active autoimmune diseases. However, participants with type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disease that do not require systemic treatment (vitiligo, psoriasis, or hair loss) may be allowed. For any uncertainty, it is recommended to consult the sponsor's medical monitor before signing the informed consent
• Received live vaccines within 2 weeks before the first IP treatment or plans to receive live vaccines during the study period
• Participants with a history of active pulmonary tuberculosis infection within 1 year, those participants with history more than 1 year prior to the first dose of IP may be considered suitable if there is no evidence of active pulmonary tuberculosis judged by Investigator

Sponsors & Collaborators

• T-MAXIMUM Pharmaceutical Inc: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (4)

The Johns Hopkins Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Hualien Tzu Chi Hospital

Hualien City, 970473, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung

Kaohsiung City, 833401, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333423, Taiwan

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Solmaz Sahebjam, MD

  The Johns Hopkins Cancer Center, Sibley Memorial Hospital

  STUDY CHAIR

• Kuo-Chen Wei, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Wang, MD

CONTACT

+1-916-214-2608; wangdan@t-maximum.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intracerebroventricular administration of 3×10\^7 cells of MT027

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 13, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3); US (1)