NCT06482905

Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.

A Phase I, Open-Label, Single/Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TX103 CAR-T Cell Injection (TX103) in Subjects With Recurrent or Progressive Grade 4 Glioma.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Tcelltech Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.

Detailed description

Eligible subjects will be enrolled into two sequential dose-escalating cohorts (i.e., A and B), and will be administrated TX103. Cohort A will receive TX103 exclusively through intraventricular (ICV) delivery, while cohort B will undergo dual intracavitary (ICT) and ICV delivery. Patients in each individual cohort will receive two TX103 infusions on Day 1 and 8 respectively, followed by a 14-day observation period in a 21-day treatment cycle. Three escalating dosage levels are planned for each cohort. Both Cohorts A and B will adopt the traditional 3+3 dose escalation design with each dose level enrolled with 3 to 6 patients. The starting dose will be 6 × 10\^7 CAR+ T cells (i.e., Dose Level 1, DL1). Dose limiting toxicities (DLTs) will be assessed during the first cycle .

Conditions

• High-grade Glioma
• WHO Grade Ⅳ Glioma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103	Safety Run-In: Dose:6×10\^7 CAR+ T cells Cohort A Single delivery route(Multi-dose)、Cohort B Dual delivery route(Multi-dose)： 3+3 dose escalation design： Dose Level 1: 6×10\^7 CAR+ T cells Dose Level 2: 1.5×10\^8 CAR+ T cells Dose Level 3: 2.5×10\^8 CAR+ T cells

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-09-01
• Completion: 2027-06-01
• First posted: 2024-07-01
• Last updated: 2026-03-24

Locations

4 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study