Health TrialsbyHealthPanel

CUE-102 in Recurrent Glioblastoma

ConditionsRecurrent GlioblastomaGlioblastomaGlioma, Malignant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Reardon, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Received any therapy for tumor recurrence other than surgery;

More than one episode of recurrent or progressive tumor;

Is currently participating or plans to participate in another study of an investigational agent or using an investigational device.

Tumor primarily localized to the brainstem or spinal cord;

Trial design

Design model

Single group

Treatments tested in this trial

  • CUE-102

    Biological/Vaccine

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: CUE-102Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Dose-limiting-toxicities (DLT)

A DLT is defined as any adverse event (AE) considered related to CUE-102 that meets DLT criteria in the 21-day period following the first dose of CUE-102 including pre-treatment laboratory results required for C2D1.

Time frame
3 weeks
2

Maximum Tolerated Dose (MTD)

MTD is determined using a 3+3 design as listed in protocol section 1.1

Time frame
3 weeks

Secondary outcomes

1

Safety and tolerability

safety and tolerability as measured by CTCAEv5.0 including clinical, laboratory, EKG and radiographic assessments.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Reardon, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Cue Biopharma

Collaborator

Source ClinicalTrials.gov
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