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.
Histologically confirmed glioblastoma.
Fresh frozen tumor tissue available for preparation of vaccine (minimum of 1.5 grams) as detailed in the investigator's brochure (IB).
No prior therapy other than surgery, or first-line therapy with standard chemoradiation.
Age ≥ 18 years.
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.
Ongoing or active infection requiring systemic treatment
Single group
B-cell vaccination
Biological/VaccineThe 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
Incidence of adverse events
Safety will be assessed by evaluating the incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0.
Progression-free survival (PFS) rate
Defined as the proportion of patients who remain alive and progression-free at six, twelve, and eighteen months from treatment initiation.
Overall survival (OS) rate
Overall survival (OS) is defined as the length of time the participant is alive after the start of treatment.
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Catalina Lee Chang
Lead sponsor
Northwestern University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
