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

NCT06468605 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Recurrent or Progressive High-grade Glioma

Interventions

BIOLOGICAL

JCXH-211

JCXH-211 is a lipid nanoparticle (LNP) encapsulated srRNA, encoding the human IL-12 protein.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-10-01
Completion
2030-10-01
FDA Drug
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468605 on ClinicalTrials.gov