ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-09-15
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05685004

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)
  2. * Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
  3. * The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
  4. * Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
  5. * 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.
  6. * Patient function assessment (Karnofsky score is \> 60)
  7. * a life expectancy of \> 12 weeks.
  8. * Hemoglobin is \> 10 g/dL (may be transfused)
  9. * White blood cell count is \> 3,000 cells/microliter (mcL) of blood.
  10. * Platelet count is \> 100,000 platelets per mcL of blood (transfusion independent)
  11. * Lymphocyte count is \> 1,000 cells/mcL of blood.
  1. * another concomitant life-threatening disease (not including glioblastoma multiforme)
  2. * a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.
  3. * requirement for treatment with glucocorticoids to control brain swelling
  4. * presence of active autoimmune disease that is currently being actively treated.
  5. * psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
  6. * Current pregnancy or a plan to become pregnant within 1-year following the study.

Contacts and Locations

Principal Investigator

Jean Aguiar, APRN
STUDY_DIRECTOR
TVAX Biomedical, Inc

Study Locations (Sites)

Center for Neurosciences
Tucson, Arizona, 85718
United States
Cedar-Sanai Medical Center
Los Angeles, California, 90048
United States
University of Southern California Keck School of Medicine
Los Angeles, California, 90048
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Aaron Mammoser
Atlanta, Georgia, 30309
United States
University of Kansas Medical Center
Kansas City, Kansas, 66061
United States
Capital Health
Pennington, New Jersey, 08534
United States
Providence St. Vincent
Portland, Oregon, 97225
United States

Collaborators and Investigators

Sponsor: TVAX Biomedical

  • Jean Aguiar, APRN, STUDY_DIRECTOR, TVAX Biomedical, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-15
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-09-15
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma Multiforme of Brain