Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma

Summary

This is a phase 1 open label study to establish the safety, tolerability, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), and preliminary efficacy of a single dose of JCXH-211. The study agent JCXH-211, is a self-replicating RNA (srRNA)-based human IL-12, administered intratumorally via convection-enhanced delivery (CED) to patients with recurrent or progressive high-grade glioma. Primary objective is to determine MTD or RP2D for a single dose on the study drug. Secondary outcomes include overall survival (OS) and progression-free survival (PFS) as assessed by modified mRANO 2.0.

Timeline

Start

2025-11-01

Primary completion

2027-10-01

Completion

2030-10-01

Drugs

Indications