Phase I Bvax for Newly Diagnosed Glioblastoma

This study is testing a new treatment called Bvax (B-cell vaccination) for people with newly diagnosed glioblastoma, a type of brain cancer. Bvax is a personalized treatment made from your own cells. It will be given along with the usual care, which includes chemoradiotherapy (chemotherapy and radiation). The main goal of this first-in-human study is to see how safe Bvax is and if it causes any side effects. Researchers also want to see if it's possible to make and give Bvax, and if it shows any early signs of helping patients. You may be able to join if you have glioblastoma confirmed by a biopsy or surgery, and enough tumor tissue is available to make the vaccine. The study plans to enroll 25 participants, but the current recruitment status is unclear.

Study design
This is a Phase I study, meaning it's one of the first times this treatment is being tested in people. It will enroll 25 participants to evaluate safety and feasibility.
What's involved
You will undergo a procedure called leukapheresis to collect blood cells. Bvax and autologous (your own) T cells will be given weekly for a total of 4 doses. After this, you may continue with standard glioblastoma care.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor you for adverse events (side effects) for up to 90 days after your first dose of Bvax and/or T-cells.

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NCT07422896

A Phase I First-in-human Trial of Bvax (B-cell Vaccination) in Addition to Standard of Care Chemoradiotherapy for Newly Diagnosed Glioblastoma

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Catalina Lee Chang
~25 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:B-cell vaccination

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 90 days after the first dose of Bvax and/or T-cell
Glioblastoma
1 sites across 1 states
Illinois1

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) FOCBP must have a negative pregnancy test before registration in the study. 10. The ability to understand and the willingness to sign a written informed consent document.
  • Incidence of adverse eventsUp to 90 days after the first dose of Bvax and/or T-cell

    Safety will be assessed by evaluating the incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0.