CAR-T Therapy for Brain Cancer

(GLIOMAX-101 Trial)

Not yet recruiting at 3 trial locations
DW
Overseen ByDan Wang, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MT027, a type of CAR-T therapy, for individuals with glioblastoma, a specific type of brain cancer. The researchers aim to determine if MT027 is safe and effective for those whose cancer has returned or worsened after standard treatments. Participants will receive an injection of MT027 directly into the brain to target cancer cells. This trial may suit those diagnosed with recurrent glioblastoma who have already tried standard treatments and whose cancer has shown signs of returning. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires a washout period (time without taking certain medications) before starting the treatment. This includes stopping chemotherapy, biologic agents, and other antitumor therapies for specific durations. It's best to discuss your current medications with the trial team to understand what changes might be needed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that MT027, a type of CAR-T therapy, has been tested in patients with brain tumors, yielding promising results. Most participants handled the treatment well, though some experienced side effects. Researchers closely monitored these side effects, particularly those involving the immune system, such as graft-versus-host disease, which occurs when donor cells attack the patient's body.

Earlier trials have shown that MT027 is generally well-tolerated. However, like many cancer treatments, side effects can occur. The therapy has demonstrated signs of controlling tumor growth, which is encouraging.

This trial is in Phase 2, meaning researchers are still gathering detailed safety information. Phase 2 trials typically focus on evaluating a treatment's safety and effectiveness. While MT027 has shown potential, more research is needed to fully understand its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, MT027 offers a novel approach by using CAR-T cell therapy. This treatment is unique because it involves genetically modifying T-cells to target a specific protein, B7-H3, found on cancer cells. Researchers are excited about MT027 because it is directly administered into the brain's ventricles, potentially allowing for more precise targeting of cancer cells with fewer side effects. This approach could offer a more effective and less toxic alternative to current therapies, providing new hope for patients with brain cancer.

What evidence suggests that MT027 might be an effective treatment for brain cancer?

Research has shown that MT027, a type of CAR-T cell therapy, targets a protein called B7H3 found on brain cancer cells. One study found that patients treated with MT027 lived for an average of 10 months, which surpasses some standard treatments. Traditional treatments often result in an average survival of 14-16 months, but options remain limited for those with recurring or worsening brain cancer. MT027 offers hope for these challenging cases. Early results suggest that MT027 may help patients with recurring brain cancer, especially glioblastoma, live longer. This treatment modifies a patient's own immune cells to better fight the cancer. Participants in this trial will receive MT027 through intracerebroventricular administration to assess its effectiveness in extending survival for those with brain cancer.16789

Who Is on the Research Team?

SS

Solmaz Sahebjam, MD

Principal Investigator

The Johns Hopkins Cancer Center, Sibley Memorial Hospital

KW

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.
See 8 more

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.
See 17 more

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?

1

Treatment groups

Experimental Treatment

Group I: MT027Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

T-MAXIMUM Pharmaceutical Inc

Lead Sponsor

Virginia Contract Research Organization Co., Ltd.

Collaborator

Trials
9
Recruited
990+

Citations

NCT06742593 | Study of MT027 in Patients with Brain, ...

MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology.

CAR-T cell therapies are coming after glioblastoma - PMC - NIH

Median overall survival (mOS) was 7.7 months; however, when considering treatment arm, a mOS of 10 versus 6 months was seen in arm 5 (14 ...

T-MAXIMUM's Allogeneic CAR-T Therapy MT027 Receives ...

Despite widespread adoption of the standard Stupp regimen, median overall survival remains only 14-16 months, with a five-year survival rate ...

T-MAXIMUM Pharmaceutical's Allogeneic CAR-T Therapy ...

Despite widespread adoption of the standard Stupp regimen, median overall survival remains only 14–16 months, with a five-year survival rate ...

CAR-T Therapy for Brain Cancer (GLIOMAX-101 Trial)

The GLIOMAX Study tests the safety and effectiveness of MT027 UCAR-T cells targeting B7H3 in patients with recurrent brain cancer. It's given ...

Study of MT027 in Patients with Brain, Meninges, and Spinal ...

MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3.

Chimeric antigen receptor (CAR) T-cell therapy for ... - PMC

Chimeric antigen receptor (CAR) T treatments in GBM trials have yielded feasibility and antitumor signals but still lack long-term control. This ...

Study of MT027 in Patients with Brain, Meninges, and ...

During the study period, adverse events were observed and recorded, with special attention paid to product-specific adverse reactions such as graft-versus-host ...

Allogeneic CAR T-Cell Therapy Elicits Responses in ...

The median overall survival exceeded 11 months in the monotherapy arm and was 13.6 months for patients who received MT027 with additional ...