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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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)

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

Condition
Glioblastoma Multiforme of Brain
Intervention / Treatment

-

Contacts and Locations

Tucson

Center for Neurosciences, Tucson, Arizona, United States, 85718

Los Angeles

Cedar-Sanai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

University of Southern California Keck School of Medicine, Los Angeles, California, United States, 90048

Orlando

Advent Health, Orlando, Florida, United States, 32801

Atlanta

Aaron Mammoser, Atlanta, Georgia, United States, 30309

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66061

Pennington

Capital Health, Pennington, New Jersey, United States, 08534

Portland

Providence St. Vincent, Portland, Oregon, United States, 97225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TVAX Biomedical,

Jean Aguiar, APRN, STUDY_DIRECTOR, TVAX Biomedical, Inc

Study Record Dates

2027-03