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

Starting soon · Phase 1

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT07422896

Run by

Catalina Lee Chang

People needed

25

Starts

2026-09-01

Expected to finish

2030-09-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• a. The Bvax drug product consists of: i. Active cellular component: Autologous CD19+ (4-1BBL+) B cells pulsed with autologous tumor lysate.
• ii. Cryopreservation medium: CryoStor® CS10 (BioLife Solutions), a current Good Manufacturing Practice (cGMP)-grade, serum-free cryoprotectant containing 10% dimethyl sulfoxide (DMSO).
• iii. Container closure system: OriGen Biomedical CryoStor® EVA freezing bag, made from biocompatible ethylene vinyl acetate (EVA).
• 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:
• i. DMSO or DMSO-containing cryoprotectants, as hypersensitivity to DMSO has been reported in other cryopreserved cell therapy products.
• ii. Excipients within CryoStor® CS10, which include pharmaceutical-grade buffer salts and electrolytes.
• iii. EVA (ethylene vinyl acetate) materials used in the cryostorage bag, for individuals with rare known contact allergies to plastics or related compounds.
• An uncontrolled intercurrent illness, including, but not limited to, the following:
• Ongoing or active infection requiring systemic treatment
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
• Psychiatric illness/social situations that would limit compliance with study requirements.
• Female patients who are pregnant or nursing. Pregnant or nursing women are excluded from this study because of the unknown risks of the study products.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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