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

Inclusion Criteria

• •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 Group (ECOG) performance status of ≤ 2
• •6. Adequate organ and bone marrow function NOTE: Transfusions or growth factors to boost counts to an eligible level are not allowed.
• •7. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• •8. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
• •9. The effects of Bvax on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of informed consent, for the duration of study participation, and for 90 days following last dose of therapy.
• •1. Should a female patient become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
• •2. Men treated or enrolled on this protocol must also agree to use adequate contraception from the time of informed consent, for the duration of study participation, and 3 months after completion of administration.
• •NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* Has not undergone a hysterectomy or bilateral oophorectomy
• •* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) FOCBP must have a negative pregnancy test before registration in the study.
• •10. The ability to understand and the willingness to sign a written informed consent document.