Phase
Condition
Gliomas
Astrocytoma
Treatment
Standard of Care (SOC): Radiation Therapy
IGV-001 Cell Immunotherapy
SOC: Temozolomide
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Has a Karnofsky performance scale (KPS) score ≥ 70 at screening
Has a new diagnosis of GBM (WHO GRADE III or Grade IV GBM) based on the treatingneurosurgeon's best clinical judgement
Has a diagnostic contrast-enhanced magnetic resonance imaging (MRI) scan with fluidattenuated inversion-recovery (FLAIR) sequence of the brain at screening.Participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm^2) in 2 different planes (axial, sagittal, or coronal)
The tumor must be located in the supratentorial compartment
Has adequate bone marrow and organ function at screening
Exclusion
Key Exclusion Criteria:
Has bi-hemispheric disease, multicentric disease, or disease burden involving thebrain stem or cerebellum based on MRI post-gadolinium enhancement
Has received any previous surgical resection or any anticancer intervention forglioma
Has any history of glioma, a concurrent malignancy, or malignancy within 3 years ofrandomization, unless definitive therapy is completed, with the exception of basalor squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ ofthe cervix or breast that has completed curative therapy
Has any severe immunocompromised condition (eg, human immunodeficiency virus (HIV)with a cluster of differentiation [CD] 4+ cell count <200*10^6/liter [L]) or anyactive uncontrolled autoimmune disease (eg, Crohn's disease)
Has an active cardiac disease or a history of cardiac dysfunction
Is receiving any other investigational agent(s) or has received an investigationalagent within 30 days or 5 half-lives of investigational agent use, whichever islonger, prior to screening
Is partaking in another interventional study. Participants who are partaking in anobservational study are eligible
Has received a live vaccine within 30 days of screening
Has active and uncontrolled/untreated hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, or any other active infections that, in the Investigator's opinion,would impair or prohibit a participant's participation in this study.
Is receiving treatment with Tumor Treating Fields or Optune®
Study Design
Connect with a study center
ChristianaCare Helen F. Graham Cancer Center and Research Institute
Newark, Delaware 19713
United StatesSite Not Available
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Mayo Clinic - Jacksonville
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Piedmont Healthcare
Atlanta, Georgia 30318
United StatesSite Not Available
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
United StatesSite Not Available
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey 07601
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
John Theurer Cancer Center At Hackensack UMC
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Northwell Health at North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Lenox Hill Hospital
New York, New York 10075
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10065
United StatesSite Not Available
Westchester Medical Center
Valhalla, New York 10595
United StatesSite Not Available
Northwell Health at North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
United StatesSite Not Available
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Lenox Hill Hospital
New York 5128581, New York 5128638 10075
United StatesSite Not Available
Weill Cornell Medicine
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Westchester Medical Center
Valhalla 5142090, New York 5128638 10595
United StatesSite Not Available
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Wake Forest
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of North Carolina (UNC) - Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
UC Health
Cincinnati, Ohio 45229
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio 43201
United StatesSite Not Available
UC Health
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
The Ohio State University (OSU) Wexner Medical Center
Columbus 4509177, Ohio 5165418 43201
United StatesSite Not Available
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19130
United StatesSite Not Available
Investigation Site
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19130
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
United StatesSite Not Available
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available
University of Wisconsin - Madison
Madison, Wisconsin 53705
United StatesSite Not Available
University of Wisconsin - Madison
Madison 5261457, Wisconsin 5279468 53705
United StatesSite Not Available

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