Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
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
Arms & interventions
- BiologicalDOC1021
Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
- ProcedureTumor resection
SOC brain tumor resection
- DrugTemodar (Temozolomide)
SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
- RadiationSOC cranial radiation
60Gy radiation over 6 weeks in 2Gy fractions
Outcome measures
Primary
Overall survival (time in months from randomization until death for each participant)
Time frame: 5 years
Secondary
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
Time frame: 1 years
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
Time frame: 2 years
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
Time frame: 3 years
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Time frame: 3 years
Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants
Time frame: 3 years
Eligibility criteria
Study locations (16)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
City of Hope
Duarte, California, 91010
HOAG
Newport Beach, California, 92663
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Cooper University Health Care
Camden, New Jersey, 08103
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Atlantic Health
Summit, New Jersey, 07901
Lenox Hill Hospital
New York, New York, 10075
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
UTHealth Houston
Houston, Texas, 77030
Baylor College of Medicine
Houston, Texas, 77057
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
References
- Georges JF, Clay C, Amin S, Goralczyk A, Mossop C, Bilbao CJ, Valeri A, Ifrach J, Zaher M, Colman L, Kohler L, Schumann EH, Vu M, Burns BA, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste KJ, Bisht N, Vazquez-Perez J, Oyewole-Said D, Amanya SB, Rodriguez V, Kraushaar DC, Okoebor D, Bellayr I, Hartenbach J, Halpert MM, Duus EM, Aguilar LK, Hsu SH, Zhu JJ, Zvavanjanja RC, Bai Y, Kang SW, Jang HJ, Lee HS, Garg R, Esquenazi Y, Tandon N, Turtz A, Konduri V, Decker WK. Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. medRxiv [Preprint]. 2026 Apr 2:2026.03.28.26349013. doi: 10.64898/2026.03.28.26349013.(PubMed)