T-MAXIMUM's B7-H3-Targeted Allogeneic CAR-T MT027 Wins FDA Clearance for a Second Phase 2 Study

T-MAXIMUM has received FDA clearance to start a second Phase 2 study of MT027, its B7-H3-targeted universal (allogeneic) CAR-T therapy, this time in brain metastases. MT027 already had FDA clearance for a Phase 2 study in recurrent glioblastoma. Together, the two studies give the company FDA-cleared Phase 2 programs covering both primary and metastatic intracranial solid tumors.

The Unmet Need in Brain Metastases

Brain metastases most often arise from lung cancer, breast cancer, melanoma, renal cell carcinoma and colorectal cancer. International estimates suggest that about 20% of cancer patients may eventually develop them, a share that can rise to 20% to 40% in people with advanced solid tumors. They can bring headaches, seizures and problems with thinking and movement, all of which affect daily life and the treatment options that remain.

The burden is global. In 2022, the world recorded close to 20 million new cancer cases, including roughly 2.5 million lung cancers and about 2.3 million breast cancers in women, the two leading sources of brain metastases. Asia accounts for about half of all new cancer cases worldwide, and in the United States an estimated 200,000 to 300,000 people are diagnosed with brain metastases each year.

Systemic drugs can act throughout the body, but reaching tumors inside the skull is harder. The blood-brain barrier, tumor diversity and the need to protect neurological function all limit what can be done. This is especially pressing for patients whose tumors keep growing in the brain after earlier treatment. They still need therapies that have been validated within the brain and that are safe and realistically accessible.

Building Toward Clinical Validation

The recent string of regulatory milestones reflects coordinated work across product design, manufacturing, clinical development and regulatory strategy, all centered on intracranial solid tumors. The company is now moving from early exploration toward more systematic clinical validation.

The clinical foundation is growing. T-MAXIMUM has built experience with local delivery, repeat dosing and safety monitoring in intracranial tumors. An investigator-initiated trial of MT026, which uses the same platform, was published in Nature Communications in 2026. Among five patients with recurrent high-grade glioma, one achieved a complete response and three had partial responses, for an objective response rate of 80%. No treatment-related Grade 3 or higher adverse events were observed.

Early data for MT027 in patients with refractory brain metastases from lung cancer were presented at the IASLC 2026 World Conference on Lung Cancer. Five heavily pretreated patients, none of whom had a guideline-recommended next treatment, completed therapy. Of the three who could be evaluated, two had partial responses. No Grade 3 or higher adverse events or graft-versus-host disease (GvHD) were reported.

On the manufacturing side, MT027 is produced using a fully non-viral gene-editing process rather than the lentiviral vector approach common across the industry. The company says this may offer advantages in safety, batch-to-batch consistency and cost control. The process was locked in before the product entered Phase 2 development.

T-MAXIMUM presents these back-to-back FDA clearances as evidence that its groundwork can be repeated and scaled across programs, not just a single first-of-its-kind achievement.

Management Perspective

Management described the two consecutive Phase 2 clearances for MT027 as a pivotal step built on sustained work in intracranial solid tumors, moving from glioma to brain metastases. They said the company will continue to assess the product's safety and potential clinical value through carefully designed studies, while steadily advancing product supply, clinical execution and the generation of key data. The aim is to open new possibilities for patients who currently have few effective treatment options.

About MT027 and T-MAXIMUM PHARMACEUTICAL

MT027 is an investigational B7-H3-targeted universal CAR-T therapy made with a fully non-viral gene-editing process and delivered locally into the intracranial space. It holds FDA Orphan Drug Designation and Fast Track Designation, and it is being studied in FDA-cleared Phase 2 trials for recurrent glioblastoma and for brain metastases from lung and breast cancer.

T-MAXIMUM PHARMACEUTICAL is a clinical-stage cell therapy company developing universal (allogeneic) CAR-T treatments for intracranial solid tumors with high unmet need, including recurrent glioblastoma and brain metastases. Its engineered cell therapies, local delivery methods and clinical translation capabilities are aimed at making treatment more accessible, including options that can be given repeatedly. MT027 is its lead program.

Forward-Looking Statements

This announcement contains forward-looking statements about the clinical development, potential benefits, manufacturing advantages and regulatory progress of MT027 and other product candidates. These statements reflect current expectations and involve risks and uncertainties, including those inherent in clinical development, regulatory review and manufacturing, which could cause actual results to differ materially. Early results from small patient groups may not predict outcomes in larger studies. MT027 is investigational, and its safety and efficacy have not been established. T-MAXIMUM is not obligated to update any forward-looking statement except as required by law.