NCT06917885

CUE-102 in Recurrent Glioblastoma

Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: David Reardon, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM). The name of the study drug involved in this study is: -CUE-102 (a type of fusion protein)

Detailed description

This is a single center, open-label, Phase Ib trial evaluating the safety and tolerability of CUE-102 monotherapy in adult participants with Glioblastoma (GBM) at first recurrence. CUE-102 is designed to target tumor cells by activating T cells, potentially improving clinical outcomes in recurrent GBM. The U.S. Food and Drug Administration (FDA) has not approved CUE-102 as a treatment for Recurrent Glioblastoma. The research study procedures include screening for eligibility, in-clinic visits, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, blood and urine tests, and electrocardiograms (ECG). It is expected that about 18 people will take part in this research study. Cue Biopharma, Inc. is supporting this research study by providing the study drug, CUE-102.

Conditions

• Recurrent Glioblastoma
• Glioblastoma
• Glioma, Malignant

Interventions

Type	Name	Description
BIOLOGICAL	CUE-102	A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-01-31
• Completion: 2028-01-31
• First posted: 2025-04-09
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study