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Brain cancer vaccine shows promise in new trial

NCT ID NCT06805305

Disease control Sponsor: Diakonos Oncology Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether adding DOC1021, a personalized dendritic cell vaccine, to standard treatment (surgery, chemo, radiation) improves survival in adults newly diagnosed with glioblastoma. About 180 participants will be randomly assigned to receive the vaccine plus standard care or standard care alone. The study measures overall survival and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DOC1021 dendritic cell vaccine
What this could lead to
If successful, this could offer a new treatment option that extends survival for people with glioblastoma, a highly aggressive brain cancer.
What could go wrong
This is a mid-stage trial with 180 participants, so results are not yet proven. The vaccine may not improve survival and could cause side effects like injection reactions or immune-related issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age 18 years or older 4. Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy. 1. Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3 residual CE tumor. Patients with subtotal resection will still be eligible if at least 70% of the CE tumor is resected. 2. Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is available, if glioblastoma IDH-wt is not confirmed, the participant will be deemed a screen failure and replaced. 3. Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated. 5. Ability to receive filgrastim (e.g., Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks. 6. Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as determined appropriate for the patient by the investigator) during study treatment. 7. Adequate kidney, liver, bone marrow function, and immune function, as follows: 1. Hemoglobin ≥ 8.0 gm/dL 2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 3. Platelet count ≥ 75,000/mm3 4. Calculated creatinine clearance (CrCl) \> 30 mL/min using Cockcroft and Gault for-mula: i. For males = (140 - age\[years\]) x (body weight \[kg\]) / (72 x serum creatinine \[mg/dL\]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 2 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN 8. Karnofsky Performance Score ≥ 70 Exclusion Criteria: 1. Infratentorial, recurrent, leptomeningeal or extracranial disease. 2. Patients who are pregnant or breastfeeding. 3. Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative also remain eligible. 4. Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to: uncontrolled or severe cardiac disease, systemic autoimmune disorders requiring immunosuppression in the past 2 years\*, autoimmune hyper/hypothyroidism, untreated viral hepatitis, autoimmune hepatitis. \*autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80/86 inhibitors, anti-CD20 and JAK inhibitors 5. Treatment with another investigational drug or other experimental intervention within the last 30 days.

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Conditions

The condition(s) this trial relates to.

glioblastoma IDH-wildtype glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma (GBM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Health

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Banner MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Gilbert, Arizona, 85234, United States

  • Baptist MD Anderson Cancer Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77057, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Cooper University Health Care

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

    Contact Email: •••••@•••••

  • HOAG

    RECRUITING

    Newport Beach, California, 92663, United States

  • Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UPMC Presbyterian Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UTHealth Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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