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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
T-MAXIMUM Pharmaceutical Inc
Study ID
NCT07386002
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jan 2026
Primary completion
Dec 13, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence rate of Dose-limiting toxicity (DLT) [ Time Frame: From the first dose to 2 weeks after the second dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Johns Hopkins Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Solmaz Sahebjam, MD
[email protected]
813-613-4120
Solmaz Sahebjam, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
The Johns Hopkins Sidney Kimmel Cancer Center· Baltimore, MD

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