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Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
Sponsor: TVAX Biomedical
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.
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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-09-15
Completion Date
2027-03
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
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 .
Locations (8)
Center for Neurosciences
Tucson, Arizona, United States
Cedar-Sanai Medical Center
Los Angeles, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Aaron Mammoser
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Capital Health
Pennington, New Jersey, United States
Providence St. Vincent
Portland, Oregon, United States