NCT05752877

Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.

Conditions

• Advanced Glioma
• Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	Targeted IL-13 Rα2 UCAR-T cell injection	local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10\^7 cells) for 1-2 minutes each time.
BIOLOGICAL	Targeted B7-H3 UCAR-T cell injection	local administration (intracranial cavity or intravertebral injection after surgery): 1 ampoule (about 2-5 ml, 1-5×10\^7 cells) for 1-2 minutes each time.

Timeline

• Start date: 2021-05-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: China