B-cell Vaccination for Glioblastoma

(Bvax Trial)

Overseen By Neurological Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Catalina Lee Chang

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled illness, Cardiac disease, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

B-cell vaccine (Bvax). As there is no control group, there is only one arm in this study.

Who Is Running the Clinical Trial?

Catalina Lee Chang

Lead Sponsor