CUE-102

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

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.

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)

Live record on ClinicalTrials.gov →

• 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 last chemotherapy cycle (at least 6 weeks for nitrosoureas and at least 1 week for metronomic dosing) and at least 4 weeks or 5 half-lives (whichever is shorter) for any prior investigational agent. There is no minimal time from cessation of Optune TTF nor for prior cancer vaccine therapy.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.