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ACTIVE NOT RECRUITING
NCT05685004
PHASE2/PHASE3

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

Sponsor: TVAX Biomedical

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TVI-Brain-1

Attenuated autologous cancer cells and activated autologous blood-derived t cells

PROCEDURE

Standard of Care

Surgery for tumor removal or debulking to minimize tumor burden

RADIATION

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.

DRUG

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