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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 15, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Glioblastoma Multiforme of Brain
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 .

Trial Locations (8)

30309

Aaron Mammoser, Atlanta

33612

Moffitt Cancer Center, Tampa

66061

University of Kansas Medical Center, Kansas City

85718

Center for Neurosciences, Tucson

90048

Cedar-Sanai Medical Center, Los Angeles

University of Southern California Keck School of Medicine, Los Angeles

97225

Providence St. Vincent, Portland

08534

Capital Health, Pennington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

TVAX Biomedical

INDUSTRY

NCT05685004 - Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) | Biotech Hunter | Biotech Hunter