RecruitingPhase 1NCT06917885

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


Sponsor

David Reardon, MD

Enrollment

18 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental cancer vaccine called CUE-102 in patients with recurrent glioblastoma (an aggressive brain tumor) that has come back after initial treatment. The vaccine is designed to activate the immune system to fight the cancer. **You may be eligible if...** - You are 18 or older with a Karnofsky performance score of 70 or higher (meaning you can care for yourself) - You have been diagnosed with Grade 4 glioblastoma or similar high-grade brain tumor at first recurrence - Your tumor carries a specific genetic marker (HLA-A*0201), determined by a blood test - You have completed prior chemotherapy and it has been at least 4 weeks since your last cycle - A recent brain MRI (within 14 days) shows stable or decreasing steroid use **You may NOT be eligible if...** - Your tumor is gliosarcoma - You have not yet received any prior treatment for your glioblastoma - You need high or increasing doses of steroids at the time of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCUE-102

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


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06917885


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