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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Catalina Lee Chang
Study ID
NCT07422896
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 90 days after the first dose of Bvax and/or T-cell ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Roger Stupp, MD
[email protected]
312-695-8143
Roger Stupp, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Northwestern University· Chicago, IL

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