{"id":"nct:NCT07897799","kind":"trial","title":"The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors","authors":["T-MAXIMUM Pharmaceutical Inc"],"author_count":1,"year":2026,"published":"2026-10-27","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07897799","source_url":"https://clinicaltrials.gov/study/NCT07897799","archive_url":"https://space-kitty.com/papers/nct:NCT07897799","updated":"2026-10-27","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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.","abstract_license":"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","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Brain Metastases From Solid Tumors"],"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"},"provenance":"clinicaltrials","attribution":"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.","topics":[{"slug":"cancer-immunotherapy","name":"Cancer Immunotherapy","domain_slug":"medicine"}],"cited_in_dossiers":[]}