CAR-T Therapy for Brain Cancer

(GLIOMAX-101 Trial)

Not yet recruiting at 3 trial locations

Overseen By Dan Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: T-MAXIMUM Pharmaceutical Inc

Must not be taking: Antiepileptics, Steroids

Disqualifiers: Brainstem recurrence, Uncontrolled seizures, Other CAR-T therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Solmaz Sahebjam, MD

Principal Investigator

The Johns Hopkins Cancer Center, Sibley Memorial Hospital

Kuo-Chen Wei, MD

Principal Investigator

Chang Gung Memorial Hospital

Are You a Good Fit for This Trial?

Adults aged 18-70 with recurrent or progressive glioblastoma (brain cancer), who've had standard treatments, can join this trial. They must have a life expectancy of at least 12 weeks, be in fair physical condition (KPS score ≥60), and have proper organ/marrow function. Participants need to provide tumor samples showing B7H3 protein presence.

Inclusion Criteria

Has adequate treatment washout period before IP treatment

Written informed consent must be obtained prior to any procedures that are not considered SOC

My condition is a recurring or worsening Grade 4 brain tumor.

Exclusion Criteria

History or active autoimmune diseases with specified exceptions

Unavailable for the follow-up assessment or concern for participant's compliance with the protocol procedures

My seizures or epilepsy have worsened, needing more medication recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MT027 via ICV injection on Day 1 & Day 15 of a 28-day cycle

28 days per cycle

2 visits per cycle (in-person)

Safety Follow-up

Participants are monitored for safety and adverse events after the last dose

1 year

Long-term Follow-up

Participants are monitored for long-term outcomes and safety

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

• MT027

Trial Overview

The GLIOMAX Study tests the safety and effectiveness of MT027 UCAR-T cells targeting B7H3 in patients with recurrent brain cancer. It's given through injections into the brain's ventricles on specific days over a cycle, with potential for ongoing treatment if tolerated well.

How Is the Trial Designed?

Group I: MT027 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

T-MAXIMUM Pharmaceutical Inc

Lead Sponsor

Virginia Contract Research Organization Co., Ltd.

Collaborator

Trials

9

Recruited

990+