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Active, not recruiting Phase 2/3

Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

NCT05685004 · tracked via the Priya Life Science USA tracker
Sponsor
TVAX Biomedical
Phase
Phase 2/3
Started
2023-12-27
Last updated
2026-09-29

Condition(s) studied

Glioblastoma Multiforme of Brain

Investigational drug(s) / intervention(s)

TVI-Brain-1Standard of CareRadiotherapyTemozolomide →

TVI-Brain-1: Attenuated autologous cancer cells and activated autologous blood-derived t cells

Standard of Care: Surgery for tumor removal or debulking to minimize tumor burden

Radiotherapy: Conformal radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks.

Temozolomide: All Subjects receive 75 mg/m2 of temozolomide daily beginning on the first day of radiotherapy and continuing until the completion of radiotherapy. Standard of care Subjects will also receive adjuvant temozolomide .

Study summary

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment) * Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines * The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department * Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits * not currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion. * Patient function assessment (Karnofsky score is \> 60) * a life expectancy of \> 12 weeks. * Hemoglobin is \> 10 g/dL (may be transfused) * White blood cell count is \> 3,000 cells/microliter (mcL) of blood. * Platelet count is \> 100,000 platelets per mcL of blood (transfusion independent) * Lymphocyte count is \> 1,000 cells/mcL of blood. Exclusion Criteria: * another concomitant life-threatening disease (not including glioblastoma multiforme) * a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin. * requirement for treatment with glucocorticoids to control brain swelling * presence of active autoimmune disease that is currently being actively treated. * psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol. * Current pregnancy or a plan to become pregnant within 1-year following the study.

Primary outcome measure(s)

  • Survival — From date of randomization until the date of death from any cause assessed up to 24 months after randomization.
    All Subjects will be evaluated and contacted to evaluate their status

Trial sites (8)

FacilityCityRegionStatus
Center for Neurosciences Tucson Arizona
Cedar-Sanai Medical Center Los Angeles California
University of Southern California Keck School of Medicine Los Angeles California
Moffitt Cancer Center Tampa Florida
Piedmont Atlanta Georgia
University of Kansas Medical Center Kansas City Kansas
Capital Health Pennington New Jersey
Providence St. Vincent Portland Oregon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685004 on ClinicalTrials.gov ↗ ← All trials in the USA