Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

Trial ID: NCT05685004

Interventional - Phase 2/3 - Active, not recruiting

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.

Conditions

• Glioblastoma Multiforme of Brain

Interventions

• TVI-Brain-1
• Standard of Care
• Radiotherapy
• Temozolomide

Eligibility

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.

Sponsor

TVAX Biomedical

Source: ClinicalTrials.gov

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