China-based clinical-stage cell therapy company T-MAXIMUM Pharmaceutical announced October 12, 2026, that FDA has cleared the company to begin a phase 2 study of MT027, its investigational B7-H3-targeted, allogeneic (donor-derived, off-the-shelf) chimeric antigen receptor (CAR) T-cell therapy, in patients with brain metastases from lung cancer or breast cancer.¹ This is the second phase 2 program for MT027 to win FDA clearance. FDA previously authorized a phase 2 study in recurrent glioblastoma, for which MT027 already holds orphan drug and fast track designations.¹
Key facts
- Drug: MT027; T-MAXIMUM Pharmaceutical
- Class: Universal (donor-derived, off-the-shelf) chimeric antigen receptor T-cell therapy
- New indication: Brain metastases from lung cancer or breast cancer
- Regulatory action: Second FDA clearance to begin a phase 2 study (after recurrent glioblastoma)
- Existing designations: Orphan drug and fast track (recurrent/high-grade glioma)
- Related program data: MT026 (IL-13Rα2 CAR-T) showed an 80% objective response rate in 5 patients with recurrent high-grade glioma
- Manufacturing: Non-viral gene-editing process, in contrast to lentiviral vector platforms
- Geography: US (FDA clearance); trials to date conducted in China
"Receiving FDA clearance for two consecutive [p]hase 2 studies of MT027 marks a pivotal step built on our sustained work in intracranial solid tumors,” said the company’s management in a press release.¹ “From glioma to brain metastases, we have always let the data speak and put clinical value first."
What clinical experience supports MT027 in the brain?
MT027 is manufactured using a non-viral gene-editing process, an alternative to the lentiviral vectors used by many competing CAR-T products, and is delivered locally into the central nervous system rather than infused systemically.¹ In an investigator-initiated trial of MT026, a related allogeneic CAR-T built on the same platform but targeting a different antigen (interleukin 13 receptor alpha 2 [IL-13Rα2]), 5 patients with recurrent high-grade glioma achieved an 80% objective response rate (1 complete response, 3 partial responses), with no treatment-related grade 3 or higher adverse events or graft-versus-host disease.¹,² In a separate, small cohort of patients with refractory brain metastases from lung cancer, presented at the 2026 World Conference on Lung Cancer, 2 of 3 evaluable patients had a partial response to MT027, again with no grade 3 or higher adverse events or graft-versus-host disease.¹
How does this clearance fit into MT027's regulatory path?
MT027's phase 2 glioblastoma study, cleared by FDA in December 2025, is registered on ClinicalTrials.gov as an open-label trial enrolling about 40 adults with recurrent or progressive glioblastoma who test positive for B7-H3 expression.³ T-MAXIMUM has not disclosed a trial registry number, planned enrollment, or start date for the new brain metastases study.¹ The company said the 2 clearances together establish MT027 as a dual-indication program spanning both primary and metastatic intracranial tumors.¹
Why does brain metastasis need its own treatment options?
Brain metastases occur most often in patients with lung cancer, breast cancer, melanoma, renal cell carcinoma, and colorectal cancer and can cause headaches, seizures, and cognitive or motor impairment.¹ Lung and breast cancer were 2 of the most common primary tumor types diagnosed worldwide in 2022, with nearly 2.5 million new lung cancer cases and about 2.3 million new female breast cancer cases.¹,⁴ Many systemic therapies have limited reach into the brain because of the blood-brain barrier, leaving surgery, radiation, or systemic therapy as the main options for patients whose disease progresses intracranially.¹
