Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06917885

CUE-102 in Recurrent Glioblastoma

Led by David Reardon, MD · Updated on 2026-03-05

18

Participants Needed

2

Research Sites

130 weeks

Total Duration

On this page

Sponsors

D

David Reardon, MD

Lead Sponsor

C

Cue Biopharma

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

CUE-102 in Recurrent Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have HLA-A*0201 genotype confirmed by local genomic testing
  • Histologically confirmed WHO Grade 4 glioblastoma or similar malignant glioma at first recurrence (excluding gliosarcoma)
  • Able and willing to provide written informed consent
  • Age 18 years or older at consent
  • Karnofsky performance status of 70 or higher
  • At least 4 weeks from last chemotherapy cycle (6 weeks for nitrosoureas, 1 week for metronomic dosing), and 4 weeks or 5 half-lives since prior investigational agent
  • MRI within 14 days before registration, with stable or decreasing corticosteroid dose for at least 5 days prior
  • Completed initial radiation therapy including 60 Gy in 30 fractions or equivalent
  • At least 12 weeks since completion of radiotherapy +/- temozolomide (exceptions allowed with specific tumor confirmation)
  • Recovered to grade 0 or 1 or pre-treatment baseline from significant toxic effects of prior therapy, except alopecia, certain lab values, and lymphopenia
  • Meet defined organ and marrow function criteria within 14 days of registration
  • Women of child-bearing potential must have negative pregnancy test within 72 hours before enrollment and agree to use highly effective contraception during and after study
  • Male participants must agree to use effective contraception or abstinence during and after study
Not Eligible

You will not qualify if you...

  • Received therapy for tumor recurrence other than surgery
  • More than one episode of recurrent or progressive tumor
  • Currently participating or planning to participate in another investigational study
  • Tumor localized primarily to brainstem or spinal cord
  • Presence of multifocal, bi-hemispheric, diffuse leptomeningeal, or extracranial disease
  • Diagnosis of immunodeficiency
  • Conditions or therapies that may interfere with participation or trial results
  • History of coagulopathy or significant hemorrhage within 12 months
  • Intratumoral or peritumoral hemorrhage beyond grade 1 or unstable
  • Recent gastrointestinal or other severe bleeding events
  • Active malignancy requiring treatment within 1 year (except certain skin or cervical cancers)
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History or current pneumonitis requiring steroids
  • Active infection needing systemic therapy within 7 days
  • Psychiatric or substance abuse disorders interfering with cooperation
  • Known HIV infection on antiretroviral therapy
  • Active Hepatitis B or C infection
  • History of non-healing wounds or recent bone refractures
  • Recent arterial thromboembolism or serious cardiovascular disease
  • Known active tuberculosis
  • Hypersensitivity to study drug or components
  • Pregnant, breastfeeding, or planning pregnancy during study and 120 days after
  • Receiving immunosuppressive therapy exceeding defined limits
  • Recent live vaccination within 30 days
  • Recent history of acute pancreatitis or significant diverticulitis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Not Yet Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

D

David Reardon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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CUE-102 in Recurrent Glioblastoma | DecenTrialz