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

NCT07422896 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: NU 25C11IND 31446
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 90 days after the first dose of Bvax and/or T-cell

Secondary Outcomes (2)

• Progression-free survival (PFS) rate

  Up to five years

• Overall survival (OS) rate

  Up to five years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

B-cell vaccine (Bvax). As there is no control group, there is only one arm in this study.

Biological: B-cell vaccination

Interventions

B-cell vaccination BIOLOGICAL

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Adequate organ and bone marrow function NOTE: Transfusions or growth factors to boost counts to an eligible level are not allowed.
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• a. The Bvax drug product consists of: i. Active cellular component: Autologous CD19+ (4-1BBL+) B cells pulsed with autologous tumor lysate.
• ii. Cryopreservation medium: CryoStor® CS10 (BioLife Solutions), a current Good Manufacturing Practice (cGMP)-grade, serum-free cryoprotectant containing 10% dimethyl sulfoxide (DMSO).
• iii. Container closure system: OriGen Biomedical CryoStor® EVA freezing bag, made from biocompatible ethylene vinyl acetate (EVA).
• There are no animal-derived proteins, adjuvants, or foreign biologicals in the final drug product. Therefore, "compounds of similar chemical or biological composition" specifically refers to:
• i. DMSO or DMSO-containing cryoprotectants, as hypersensitivity to DMSO has been reported in other cryopreserved cell therapy products.
• ii. Excipients within CryoStor® CS10, which include pharmaceutical-grade buffer salts and electrolytes.
• iii. EVA (ethylene vinyl acetate) materials used in the cryostorage bag, for individuals with rare known contact allergies to plastics or related compounds.
• An uncontrolled intercurrent illness, including, but not limited to, the following:
• Ongoing or active infection requiring systemic treatment
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia

Sponsors & Collaborators

• Catalina Lee Chang: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Neurological Surgery

CONTACT

312-695-8143; braintumortrials@nm.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)