A Phase I First-in-human Trial of Bvax (B-cell Vaccination) in Addition to Standard of Care Chemo… (NCT07422896) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I First-in-human Trial of Bvax (B-cell Vaccination) in Addition to Standard of Care Chemoradiotherapy for Newly Diagnosed Glioblastoma
United States25 participantsStarted 2026-09-01
Plain-language summary
The objectives of this phase I first-in-human trial are to evaluate safety, feasibility, and preliminary efficacy of an individualized Bvax vaccine in addition to standard of care chemoradiation in patients with newly diagnosed glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed glioblastoma.
. Fresh frozen tumor tissue available for preparation of vaccine (minimum of 1.5 grams) as detailed in the investigator's brochure (IB).
. No prior therapy other than surgery, or first-line therapy with standard chemoradiation.
. Age ≥ 18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
. Adequate organ and bone marrow function NOTE: Transfusions or growth factors to boost counts to an eligible level are not allowed.
. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 90 days after the first dose of Bvax and/or T-cell
. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
Exclusion criteria
. Have not recovered from adverse events from surgery or the ongoing chemoradiotherapy (i.e., have residual toxicities \> Grade 2) with the exception of alopecia.
. Receiving any other investigational agents.
. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Bvax.
. There are no animal-derived proteins, adjuvants, or foreign biologicals in the final drug product. Therefore, "compounds of similar chemical or biological composition" specifically refers to:
. An uncontrolled intercurrent illness, including, but not limited to, the following:
. Ongoing or active infection requiring systemic treatment