Beijing – September 21, 2026 -- T-MAXIMUM Pharmaceutical reported that two of three evaluable patients with refractory brain metastases from lung cancer achieved partial responses with roughly 80% tumor shrinkage after treatment with its allogeneic B7-H3-targeted CAR-T therapy, MT027, according to early data presented at the IASLC World Conference on Lung Cancer (WCLC 2026) in Seoul.
Two of three evaluable patients hit 80% tumor shrinkage in dose-escalation trial
In the prospective, investigator-initiated trial (ChiCTR2500107346), five patients with heavily pretreated, guideline-exhausted brain metastases completed treatment. Of the three with measurable disease, two achieved partial responses and one achieved stable disease. As of the company's September 2026 follow-up, the two responders have survived more than 11 and 13 months, respectively, since their first MT027 dose, and all three evaluable patients remain alive.
No Grade 3+ toxicity or GvHD reported across five treated patients
Safety data showed no drug-related Grade 3 or higher adverse events and no graft-versus-host disease among the five patients; adverse reactions were limited to Grade 1-2 immune-inflammatory reactions. MT027 was administered via intracerebroventricular or lumbar intrathecal routes, delivering the allogeneic, off-the-shelf cell therapy directly into the cerebrospinal fluid compartment near intracranial lesions.
Two B7-H3 ADCs post Phase III wins the same day, exposing a brain-metastases gap
The presentation followed same-day Phase III readouts from two B7-H3-targeted antibody-drug conjugates in second-line small cell lung cancer, validating B7-H3 as a target for systemic disease. T-MAXIMUM frames MT027 as an "inside-out" complement to those "outside-in" ADC approaches, arguing that large-molecule ADCs depend on passive diffusion across the blood-brain barrier and face uncharacterized linker and payload behavior in the central nervous system, while CAR-T cells actively migrate toward tumors and can persist in cerebrospinal fluid. No head-to-head comparison between the two modalities has been conducted.
FDA clearance and two special designations already back MT027 in glioblastoma
MT027 has been cleared by the U.S. FDA for a Phase II study in recurrent glioblastoma and holds Fast Track Designation for that indication, alongside Orphan Drug Designation in high-grade glioma. A global multicenter Phase II study in recurrent glioma is currently underway, and the company said it will use accumulated experience in local administration, repeat dosing and safety monitoring to advance MT027 into brain metastases as a second indication.
T-MAXIMUM said it will continue generating clinical data, maintain regulatory dialogue, and advance its clinical research plans, noting that MT027 remains investigational and has not been approved by the FDA or any other regulatory authority.