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ACTIVE NOT RECRUITING
NCT05241392
PHASE1

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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

BIOLOGICAL

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