Catalina Lee Chang
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 f…
Inclusion Criteria (for study participation) 1. Histologically confirmed glioblastoma. a. Adequate tissue is required for confirmation of diagnosis; a formalin-fixed and paraffin-embedded (FFPE) tissue block must be available for confirmation of diagnosis and possible additional molecular studies (if applicable) 2. Fresh frozen tumor tissue available for preparation of vaccine (minimum of 1.5 grams) as detailed in the investigator's brochure (IB). 3. No prior therapy other than surgery, or first-line therapy with standard chemoradiation. 4. Age ≥ 18 years. 5. Eastern Cooperative Oncology…
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
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