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

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.

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.