B-cell Vaccination for Glioblastoma

(Bvax Trial)

NS
Overseen ByNeurological Surgery
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new B-cell vaccine, called Bvax, to determine its safety and effectiveness when combined with standard chemotherapy and radiation for individuals newly diagnosed with glioblastoma, a type of brain cancer. Researchers aim to discover if this personalized vaccine can enhance the immune system's ability to combat the cancer. Individuals with confirmed glioblastoma who have not received treatments other than surgery or initial chemoradiation may qualify for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that the Bvax vaccine is likely to be safe for humans?

Research has shown that vaccines like Bvax, used to treat glioblastoma, are generally well-tolerated. In studies, serious side effects occurred in about 15% to 52% of patients, but these side effects can usually be managed. While some patients experience significant side effects, many do not, and those who do can often be treated successfully. This indicates a positive sign for the treatment's safety, although it remains in the early stages of testing.12345

Why do researchers think this study treatment might be promising for glioblastoma?

Researchers are excited about Bvax for glioblastoma because it uses a novel approach by employing a B-cell vaccine, a departure from traditional treatments like surgery, chemotherapy, and radiation. Unlike these standard options, which target cancer cells directly, Bvax aims to boost the body’s immune system to recognize and attack glioblastoma cells more effectively. This innovative mechanism could offer a more targeted and potentially less toxic approach to tackling this aggressive brain cancer, providing hope for improved outcomes.

What evidence suggests that the Bvax vaccine might be an effective treatment for glioblastoma?

Studies have shown promising results for the Bvax vaccine in treating glioblastoma, a type of brain cancer. In one study, patients who received a similar cancer vaccine lived an average of 21.9 months, compared to 14.6 months with standard treatments. Another study found that vaccines like Bvax can help the immune system attack glioma cells. These early findings suggest that Bvax, the sole treatment in this trial, may improve survival rates and strengthen the immune response against glioblastoma.34678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed glioblastoma who have not had prior treatments except surgery or standard chemoradiation. Participants need to have enough tumor tissue available, good organ and bone marrow function, and be able to perform daily activities independently.

Inclusion Criteria

I have at least 1.5 grams of fresh frozen tumor tissue available for testing.
I have been diagnosed with glioblastoma by a tissue test.
I have enough preserved tumor tissue available for testing.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and Vaccine Production

Leukapheresis for collection of PBMCs to produce Bvax, followed by vaccine production during chemoradiation

4 weeks

Vaccine Administration

Weekly administration of Bvax and autologous T cells for a total of 4 doses

4 weeks
4 visits (in-person)

Adjuvant Treatment

Patients may resume standard of care with adjuvant TMZ with or without Tumor Treating Fields

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days after the first dose of Bvax and/or T-cell

What Are the Treatments Tested in This Trial?

Interventions

  • Bvax

Trial Overview

The study is testing a personalized B-cell vaccine (Bvax) given alongside the usual chemoradiotherapy for glioblastoma. This early-phase trial mainly looks at safety and feasibility in people receiving this new treatment combination.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Catalina Lee Chang

Lead Sponsor

Citations

Promising Cancer Vaccine for Glioblastoma Therapy - PMC

The median OS was 394 days (13.0 months) (95% CI 309–648). The overall immune‐related response rate in solid tumor patients was 7.5% (95% CI 2.6 ...

167 B-cell-based vaccination elicit potent immunity against ...

GBM patient-derived BVax were successful in activating autologous CD8+ T cells; these T cells showed a strong ability to kill autologous glioma ...

Imvax Announces Positive Results from Clinical Trial of ...

Median overall survival was 21.9 months for highest vaccine dose vs. 14.6 months in published standard of care studies.

A 5-Year Update on the Clinical Development of Cancer ...

The median overall survival (OS) was 19 months, signifying that half of the patients survived for over a year and a half after diagnosis [43].

New concepts for glioblastoma vaccine immunotherapy

A Phase II trial demonstrated safety and disease stabilization in recurrent GBM [54]. However, a subsequent Phase III trial combining DSP-788 ...

Review article Active immunization strategies in glioblastoma

Grade 3 or higher adverse events ranged from approximately 15% to 52% across interventions and were generally manageable. Baseline corticosteroid exposure ...

Recent developments in peptide vaccines against ... - PMC

A one-year survival rate of 36% was achieved, with a mOS of 24.7 weeks [100]. Trials are examining the safety and effectiveness of the WT-1 ...

Early Data for Glioblastoma Vaccine

A clinical trial of the CVGBM cancer vaccine showed positive T-cell responses in over 75% of glioblastoma patients.