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OncoMatch/Clinical Trials/NCT03382977

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

Is NCT03382977 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including VBI-1901 and Carmustine for glioblastoma multiforme.

Phase 1/2RecruitingVBI Vaccines Inc.NCT03382977Data as of May 2026

Treatment: VBI-1901 · Carmustine · LomustineThe purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM).

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

Required: IDH2 wild-type

Disease stage

Required: Stage IV (WHO)

Grade: IV (WHO)

WHO grade IV glioblastoma; measurable disease

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: surgery — initial therapy

An initial therapy requires surgery and radiation therapy, with or without temozolomide. In addition, alternate therapy (with or instead of temozolomide) is permitted as part of initial therapy.

Must have received: radiation therapy — initial therapy

An initial therapy requires surgery and radiation therapy, with or without temozolomide. In addition, alternate therapy (with or instead of temozolomide) is permitted as part of initial therapy.

Cannot have received: immunotherapy

Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic vaccination, or biologics (e.g. monoclonal antibodies, such as bevacizumab) presumed to have immunomodulatory effects.

Cannot have received: systemic therapy after first recurrence

Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease.

Cannot have received: Optune (Optune)

Exception: Previous use of Optune in the primary setting does not preclude participation in this clinical trial.

Concurrent therapy with Optune® or use within 1 week of start of treatment. Previous use of Optune® in the primary setting does not preclude participation in this clinical trial.

Lab requirements

Blood counts

ANC ≥ 1,000/μL, platelets ≥ 100,000/μL; absolute lymphocyte count ≥ 500/uL; CD4/CD8 ratio ≥1 or CD4 count ≥ 400/uL

Kidney function

Serum creatinine < 1.5 × ULN

Liver function

Bilirubin < 1.5 × ULN; ALT and AST < 2.5 × ULN

Adequate organ function, including: ANC ≥ 1,000/μL, platelets ≥ 100,000/μL; absolute lymphocyte count ≥ 500/uL; CD4/CD8 ratio ≥1 or CD4 count ≥ 400/uL; Serum creatinine < 1.5 × ULN; Bilirubin < 1.5 × ULN; ALT and AST < 2.5 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, Irvine · Irvine, California
  • University of California, San Diego · La Jolla, California
  • University of California, Los Angeles Neuro-Oncology Program · Los Angeles, California
  • Stanford · Stanford, California
  • Miami Cancer Institute · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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