The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors

Brief summary

This is a prospective, open-label, multicenter, single arm Phase II trial to evaluate the safety, tolerability, intracranial efficacy, pharmacokinetics, and pharmacodynamics of MT027 administered ICV in patients with B7-H3-positive brain metastases from advanced solid tumors. The trial consists of two sequential stages: a safety run-in stage followed by a dose expansion stage. Approximately 40 participants are planned for enrollment, including approximately 3 to 6 participants in the safety run in stage and 34 participants in the dose expansion stage. The final number of participants enrolled may vary depending on the safety findings observed during the safety run-in stage. Approximately 3 to 6 eligible participants from the primary target population will receive MT027 3×107 CAR+ T cells via ICV injection on Days 1 and 15 of each 28-day cycle. DLTs will be assessed during a 28-day DLT observation period following the first dose. Following SRC confirmation of acceptable safety during the safety run-in stage, an additional 34 participants will be enrolled to evaluate the intracranial efficacy of MT027 dosed at 3×107 CAR+ T cells.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

METAMAX-101

status

NOT_YET_RECRUITING

phase

PHASE2

study type

INTERVENTIONAL

enrollment

40

sponsor

T-MAXIMUM Pharmaceutical Inc

conditions

Brain Metastases From Solid Tumors

interventions

BIOLOGICAL: Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3

start date

2027-12-30

start date type

ESTIMATED

primary completion date

2029-12-20

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters