DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
Start Date
3/17/2025
Completion Date
3/1/2032
Summary
The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses * Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: \- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
DOC1021
Tumor resection
Temodar (Temozolomide)
SOC cranial radiation
Conditions
Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
City of Hope
Duarte, California 91010
United States
HOAG
Newport Beach, California 92663
United States
UCSF
San Francisco, California 94143
United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02115
United States
Cooper University Health Care
Camden, New Jersey 08103
United States
Rutgers Cancer Institute
New Brunswick, New Jersey 08901
United States
Atlantic Health
Summit, New Jersey 07901
United States
Lenox Hill Hospital
New York, New York 10075
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37203
United States
UTHealth Houston
Houston, Texas 77030
United States
Baylor College of Medicine
Houston, Texas 77057
United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States