A Phase II, Open-label, Multicenter Trial With a Safety Run-in to Evaluate the Safety, Tolerability, Intracranial Efficacy, Pharmacokinetics, and Pharmacodynamics of MT027 Administered Intracerebroventricularly in Patients With B7-H3-positive Brain Metastases From Advanced Solid Tumors

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.

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No