Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:25 PM
Study NCT ID:
NCT07386002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma
Sponsor:
T-MAXIMUM Pharmaceutical Inc
Organization:
Study Overview
Official Title:
A Phase II, Open-Label, Multicenter Study With a Safety Run-In to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of MT027 Administrated Intracerebroventricularly in Patients With Recurrent or Progressive Glioblastoma (WHO Grade 4)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLIOMAX-101
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.
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.
Detailed Description:
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.
The study will begin with a safety run-in of 3 to 6 participants to evaluate the safety and tolerability of MT027 at a dose of 3×10\^7 cells. Once the DLT assessment is complete, an additional 34 participants will be enrolled, bringing the total to 40, to evaluate the treatment's efficacy. Each participant will undergo screening, treatment, safety follow-up, and long-term follow-up periods. Any participant who has discontinued from study treatment other than disease progression will also continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, withdrawal from the study, or death, whichever comes first. Upon completion of the safety follow-up, all patients, except those who died, withdrew consent, or were lost to follow-up, will enter to the long-term follow-up. It is regarded as the end of the study when the last participant has completed the 1-year long-term follow-up, or all participants have progressed, died, or lost to follow-up, whichever comes first. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle, and the DLT observation period will be 28 days following the first dose of the first cycle (only for safety run-in group). After the DLT observation period, if the participant does not experience any unacceptable toxicities and disease progress, 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. When confirming disease progression, the study treatment may still be continued if there's a potential for benefit, based on PI's discretion and the participant's willingness, particularly when there are no better treatment options available. Investigational product (IP) may be temporarily interrupted to allow safety management and will resume the study treatment dose after participant's adverse events are recovered to the Grade 1 level or baseline, per PI's discretion. 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.
The study will begin with a safety run-in of 3 to 6 participants to evaluate the safety and tolerability of MT027 at a dose of 3×10\^7 cells. Once the DLT assessment is complete, an additional 34 participants will be enrolled, bringing the total to 40, to evaluate the treatment's efficacy. Each participant will undergo screening, treatment, safety follow-up, and long-term follow-up periods. Any participant who has discontinued from study treatment other than disease progression will also continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, withdrawal from the study, or death, whichever comes first. Upon completion of the safety follow-up, all patients, except those who died, withdrew consent, or were lost to follow-up, will enter to the long-term follow-up. It is regarded as the end of the study when the last participant has completed the 1-year long-term follow-up, or all participants have progressed, died, or lost to follow-up, whichever comes first. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle, and the DLT observation period will be 28 days following the first dose of the first cycle (only for safety run-in group). After the DLT observation period, if the participant does not experience any unacceptable toxicities and disease progress, 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. When confirming disease progression, the study treatment may still be continued if there's a potential for benefit, based on PI's discretion and the participant's willingness, particularly when there are no better treatment options available. Investigational product (IP) may be temporarily interrupted to allow safety management and will resume the study treatment dose after participant's adverse events are recovered to the Grade 1 level or baseline, per PI's discretion. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: