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

Recurrent Malignant Glioma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05540873
Study type Interventional
Source CellabMED
Contact Sungmin Jun
Phone +82262048381
Email smjun@cellabmed.com
Status Recruiting
Phase Phase 1
Start date July 18, 2022
Completion date April 30, 2024
View Details
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