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

Sponsor: TVAX Biomedical

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05685004

Provider View

This clinical trial is testing a new treatment that combines a personalized vaccine and T cell therapy with standard treatment for patients with a specific type of brain cancer called MGMT negative glioblastoma. The study aims to see if this combination is more effective than standard treatment alone.

Patient Parameters

Program Overview

The study is exploring a new treatment approach for patients with newly diagnosed MGMT negative glioblastoma, a type of brain cancer. It involves using the patient's own cancer cells to create a vaccine that boosts the immune system. This vaccine is combined with standard treatment to see if it can better fight the cancer. The process includes collecting cancer cells after surgery, creating a vaccine, and then using the patient's own T cells to attack the cancer. These T cells are collected, stimulated, and then infused back into the patient after standard treatment.

Description

This study is testing a new treatment for patients with a specific type of brain cancer called MGMT negative glioblastoma. The treatment combines a personalized vaccine made from the patient's own cancer cells with standard therapy, which includes surgery, radiation, and chemotherapy. The goal is to see if this combination is more effective than standard treatment alone.

Patients in the study will have their cancer cells collected after surgery. These cells are used to create a vaccine that helps the immune system recognize and attack the cancer. Patients will receive two doses of this vaccine. Additionally, T cells, a type of immune cell, will be collected from the patient's blood, stimulated to become more active, and then infused back into the patient after they complete standard treatment.

All patients will have regular follow-up visits, including MRI scans, to monitor their progress and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with MGMT negative glioblastoma multiforme and have not received prior treatment.
  • Enough cancer tissue available to create a personalized vaccine.
  • The vaccine meets quality standards set by the study.
  • Recent medical tests show normal kidney and liver function.
  • Not currently taking steroids and have stopped them at least 24 hours before receiving the vaccine and T cell infusion.
  • Able to perform daily activities with a Karnofsky score over 60.
  • Expected to live more than 12 weeks.
  • Hemoglobin level over 10 g/dL (transfusions allowed).
  • White blood cell count over 3,000 cells/mcL.
  • Platelet count over 100,000 platelets/mcL (without needing transfusions).
  • Lymphocyte count over 1,000 cells/mcL.

Exclusion Criteria

  • Have another life-threatening disease besides glioblastoma.
  • Have a second cancer that is not in remission, except for certain skin cancers.
  • Need steroids to control brain swelling.
  • Have an active autoimmune disease that requires treatment.
  • Have conditions that prevent proper medical follow-up or compliance with the study.
  • Are currently pregnant or planning to become pregnant within a year after the study.

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