NCT05540873

A Clinical Study of IL13Rα2 Targeted CAR-T in Patients With Malignant Glioma (MAGIC-I)

A Single-center, Single-arm, Open-label Phase 1 Clinical Trial to Assess the Safety and Tolerability of YYB-103, IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell (CAR-T) in Treating Patients With Refractory or Recurrent Malignant Glioma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: CellabMED · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study to evaluate the safety and tolerability of IL13Rα2 Targeted Chimeric Antigen Receptor-T Cell in patients with Refractory or Recurrent Malignant Glioma and to evaluate the changes of AE incidence. And this study have to long term follow-up.

Detailed description

This is a single-center, single-arm, open-label phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts. The objectives of this study is to assess the safety and tolerability after administration of YYB-103 (IL13Rα2 targeted CAR-T cell) in patients with malignant glioma. YYB-103 is designed to target cancer cells expressing IL13Rα2 in cell surface. Only those subjects who are expressing IL13Rα2 and satisfy the inclusion and exclusion criteria will receive IV infusion of YYB-103. Long term follow-up study is evaluate the safety and exploratory efficacy of IP for 15 years from the date of IP administration in patients with malignant glioma refractory or recurrent to standard therapy who participated in this study. Subjects who participated in the Phase 1 study and received YYB-103 must have long-term follow-up for 15 years from the date of administration. During the long-term follow-up period, AEs, exploratory efficacy etc. are observed, and the observation period is every 6 months within 5 years and then yearly until 15 years.

Conditions

• Recurrent Malignant Glioma

Interventions

Type	Name	Description
DRUG	YYB-103	Biological: IL13Rα2 CAR-T cells Administration method: intravenous infusion YYB-103 is manufactured according to the subject's assigned dose group and body weight.

Timeline

• Start date: 2022-07-18
• Primary completion: 2024-02-28
• Completion: 2024-04-30
• First posted: 2022-09-15
• Last updated: 2023-01-06

Locations

1 site across 1 country: South Korea