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Brain cancer vaccine trial aims to boost Chemo's punch

NCT ID NCT07365280

Disease control Sponsor: ZSky Biotech Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests a personalized dendritic cell vaccine (ZSNeo-DC1.1) combined with standard chemotherapy (temozolomide) in 78 adults with newly diagnosed glioblastoma. Participants receive the vaccine as shots during chemo after surgery and radiation. The goal is to see if the combo improves how long the cancer stays under control compared to chemo alone.

What this could mean

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

Active substance
personalized dendritic cell vaccine (ZSNeo-DC1.1) plus temozolomide chemotherapy
What this could lead to
If it works, this could offer a new way to extend survival for people with glioblastoma, a tough-to-treat brain cancer.
What could go wrong
This is a small, early-phase trial (78 people) with no results yet. The vaccine is personalized, which is complex, and it may not improve outcomes or could cause side effects.

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 78 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 to 75 years

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: Participants must meet all the following criteria to be eligible: Inclusion Criteria 1. Age 18 to 75 years, inclusive 2. Histologically confirmed newly diagnosed glioblastoma (WHO grade IV) 3. Molecular diagnosis of IDH1/IDH2 wild-type 4. Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy 5. Karnofsky Performance Status (KPS) score of 50 to 100 6. Adequate hematologic, hepatic, renal, and coagulation function 7. Availability of sufficient tumor tissue and blood samples for neoantigen identification 8. Adequate venous access for PBMC collection 9. Life expectancy greater than 3 months 10. Willingness to use effective contraception during study treatment and for 3 months thereafter 11. Ability to understand and willingness to sign written informed consent Exclusion Criteria: Exclusion Criteria: Subjects meeting any of the following criteria are ineligible: 1. Not suitable for standard temozolomide-based chemoradiotherapy 2. Prior participation in another interventional clinical trial within 4 weeks before randomization 3. Prior implantation of carmustine wafers within 6 months 4. Known hypersensitivity to temozolomide or dacarbazine 5. Active autoimmune disease or requirement for systemic immunosuppressive therapy 6. Active infection including HIV, active hepatitis B or C, or syphilis 7. Use of systemic immunosuppressive therapy within 30 days before randomization 8. Uncontrolled cardiovascular, metabolic, or systemic disease 9. Pregnancy or breastfeeding 10. Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

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

Glioblastoma

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.