CUE-102 for Glioblastoma

Recruiting at 1 trial location

Overseen By David Reardon, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: David Reardon, MD

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Active infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: up to 1 year

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on assessing the safety of an experimental drug, CUE-102, for individuals with recurrent glioblastoma, a type of brain cancer. Researchers aim to determine the safest dose of CUE-102 that patients can tolerate. Ideal participants have a confirmed diagnosis of recurrent glioblastoma and are at least 12 weeks post-radiation therapy. This trial does not suit those with tumors that have spread to other areas or those with a history of certain serious health conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must be at least 4 weeks from your last chemotherapy cycle and cannot be on certain immunosuppressive therapies or high-dose corticosteroids before enrolling. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that CUE-102 is likely to be safe for humans?

Research has shown that CUE-102 is a new drug being tested to treat recurrent glioblastoma, a type of brain cancer. It helps the immune system attack the cancer. The FDA approved the start of this study because earlier tests found a similar drug, CUE-101, to be safe.

While detailed reports on the side effects of CUE-102 are not yet available, current studies aim to find the optimal dose with the fewest side effects. This early stage of testing ensures the treatment is safe and well-tolerated. Researchers will closely monitor participants to identify any issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CUE-102 is unique because it targets glioblastoma differently from traditional treatments like surgery, radiation, and chemotherapy. While most treatments focus on destroying cancer cells directly, CUE-102 is designed to enhance the body's immune response against the tumor. Researchers are excited about CUE-102 because it could potentially offer a more targeted approach, reducing damage to healthy cells and possibly improving outcomes for patients with this aggressive brain cancer.

What evidence suggests that CUE-102 might be an effective treatment for Glioblastoma?

Research shows that CUE-102, the investigational treatment studied in this trial, is designed to help the body's immune system attack cancer cells by activating certain immune cells called T cells. These T cells target a protein known as Wilms' Tumor 1, often found in cancers like glioblastoma, a type of brain cancer. By activating these T cells, the treatment may improve outcomes for people with recurrent glioblastoma. Early results suggest this approach could be a promising way to fight this difficult-to-treat cancer. The aim is to help patients live longer and enjoy a better quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

David Reardon, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults over 18 with recurrent Grade 4 glioblastoma or malignant glioma, who've completed initial radiation and chemotherapy. They must not be pregnant, agree to use contraception, have specific organ and marrow function, no severe autoimmune diseases or infections, stable corticosteroid doses, a Karnofsky performance status ≥ 70, and no recent significant cardiovascular issues.

Inclusion Criteria

I have completed my initial radiation therapy as prescribed.

Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 72 hours prior to enrollment and agree to use highly effective contraception

My organ and bone marrow functions meet the required health standards.

Exclusion Criteria

My tumor is mainly in my brainstem or spinal cord.

My tumor has come back or gotten worse more than once.

I don't have any health issues that could affect the trial's results or my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CUE-102 daily for up to 1 year, with imaging every 9 weeks starting at Cycle 3

up to 1 year

17 cycles, Day 1 of 21-day cycle

End of Treatment

End of Treatment visit with imaging to assess response

Long-Term Follow-up

Participants are monitored every 3-4 months for safety and effectiveness after treatment

every 3-4 months

What Are the Treatments Tested in This Trial?

Interventions

• CUE-102

Trial Overview The trial is testing the safety of CUE-102 (a fusion protein) for treating recurrent Glioblastoma. It aims to establish the recommended dose for patients by monitoring their response and any side effects that occur during treatment.

How Is the Trial Designed?

Group I: CUE-102 Experimental Treatment 1 Intervention

The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete: * Baseline visit * Imaging every 9 weeks starting at Cycle 3 * Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles) --Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily. * End of Treatment visit with imaging * Long-Term Follow Up: every 3-4 months

Who Is Running the Clinical Trial?

David Reardon, MD

Lead Sponsor

Cue Biopharma

Industry Sponsor

Trials

3

Recruited

160+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06917885

NCT06917885 | CUE-102 in Recurrent Glioblastoma CUE-102 is designed to target tumor cells by activating T cells, potentially improving clinical outcomes in recurrent GBM.

2. cuebiopharma.gcs-web.com cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-announces-initiation-investigator-sponsored-trial

Cue Biopharma Announces Initiation of Investigator ... “CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM.” Matteo ...

3. rarecancernews.com rarecancernews.com/news/patients-needed-us-trial-testing-cue-102-recurrent-glioblastoma/

Patients needed for trial of CUE-102 for hard-to-treat ... “CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent [glioblastoma].”

4. trial.medpath.com trial.medpath.com/news/9c9e584bce4a856a/cue-biopharma-initiates-phase-1b-trial-of-cue-102-for-recurrent-glioblastoma-at-dana-farber

Cue Biopharma Initiates Phase 1b Trial of CUE-102 for ... The study evaluates CUE-102, an IL-2-based biologic targeting Wilms' Tumor 1 protein, in patients with glioblastoma at first recurrence under ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8384724/

Glioblastoma Multiforme (GBM): An overview of current ... Glioblastoma multiforme (GBM) is a WHO grade IV glioma and the most common malignant, primary brain tumor with a 5-year survival of 7.2%.

6. cuebiopharma.com cuebiopharma.com/wp-content/uploads/2023/03/Cue-Corporate-Presentation-March-2023-FINAL.pdf

Cue Biopharma, Inc. ➢ FDA authorized CUE-102 IND based on the safety data from CUE-101 with no requirement for IND-enabling toxicology and approval to start the trial at a ...

7. withpower.com withpower.com/trial/phase-1-glioblastoma-8-2025-fe1da

CUE-102 for Glioblastoma This Phase 1 medical study run by David Reardon, MD is evaluating whether CUE-102 will have tolerable side effects & efficacy for patients with Glioblastoma ...