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Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Sponsor: Beijing Tiantan Hospital
Summary
This is an open-label, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability, and preliminary efficacy of TX103-CAR-T Cell Injection, a B7-H3-targeting chimeric antigen receptor T-cell (CAR-T) therapy, in patients with recurrent glioblastoma. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103-CAR-T Cell Injection.
Official title: An Open, Single-arm, Phase 1 Study to Evaluate the Safety/Preliminary Effectiveness and Determine the Maximal Tolerated Dose of B7-H3-targeting CAR-T Cell Therapy in Treating Recurrent Glioblastomas
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2022-01-27
Completion Date
2026-12-31
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
B7-H3-targeting CAR-T cells/TX103-CAR-T Cell Injection
Patients will be treated with anti-B7-H3 autologous CAR-T cells that are delivered into the intracranial tumor resection cavity or ventricular system using an Ommaya device.
Locations (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China