NCT07422896

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Catalina Lee Chang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be enrolled following surgery or biopsy, confirming the diagnosis of glioblastoma. Leukapheresis may start any time after enrollment and before the start of adjuvant temozolomide (TMZ), ideally prior to starting radiation therapy (RT) with concomitant TMZ chemoradiation. Bvax vaccine production will occur during chemoradiation (TMZ/RT). Patients will first undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC) to produce Bvax. The CD19+ B cells will then be enriched for 4-1BBL+ cells that will be expanded in a cell culture and primed with tumor lysate from the patient's tissue. After passing quality control, the Bvax product will be cryopreserved at - 135oC. During the same process the CD8 T cells will be cryopreserved without further manipulation or expansion. Vaccine administration consisting of Bvax and autologous T cells will occur weekly, for a total of 4 doses. After completion of Bvax, patients may resume standard of care (SOC) with adjuvant TMZ with or without Tumor Treating Fields (TTFields), as clinically indicated.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	B-cell vaccination	The study treatment includes dose-escalation of B-cell vaccine (Bvax) and a fixed dose of autologous CD8 T cells reinfusion integrated in the standard of care therapy for glioblastoma. Bvax is a biological product that is produced for each patient individually from the cells collected through leukapheresis. The Bvax treatment will be administrated once a week for a total of 4 doses. The following dose levels (DL) will be explored: * DL1: 0.5 x 106 Bvax/kg/injection and 2 x 106/kg/injection. * DL 2: 1.0 x 106 Bvax/kg/injection and T cells 2 x 106/kg/injection

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2030-06-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study