Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence
David Reardon, MD
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)
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,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have HLA-A\*0201 genotype as determined by genomic testing performed locally; * Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. Patients with gliosarcoma are NOT eligible; * Be willing and able to provide written informed consent/assent for the trial; * Be ≥ 18 years of age on day of signing informed consent; * Have a Karnofsky performance status (KPS) ≥ 70 (Appendix A); * Participants must be at least 4 weeks from start of l…
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 HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts