RecruitingPhase IIEN originalGlioma (brain cancer)

DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjent musi wyrazić świadomą zgodę na udział w badaniu i przestrzegać jego zasad.
  • Pacjent musi mieć ukończone 18 lat.
  • Pacjent ma zdiagnozowanego glejaka mózgu (typ IDH-wt), który nadaje się do usunięcia operacyjnego.
  • Celem operacji jest całkowite lub prawie całkowite usunięcie guza.
  • Pacjent nie przyjmował wcześniej żadnego leczenia przeciwnowotworowego.
  • Pacjent musi być zdolny do przyjęcia leku filgrastim, przejścia zabiegu pobrania komórek krwi (leukaferezy) oraz otrzymać zastrzyki DOC1021 i pIFN.
  • Kobiety w wieku rozrodczym muszą mieć negatywny test ciążowy i stosować skuteczną antykoncepcję.
  • Pacjent musi mieć prawidłowe wyniki badań krwi (hemoglobina, liczba neutrofilów, płytki krwi) oraz odpowiednią funkcję nerek i wątroby.

✗ Disqualifies

  • Pacjenci, którzy otrzymali już jakiekolwiek leczenie przeciwnowotworowe z powodu glejaka mózgu, z wyjątkiem dodatkowej resekcji guza.
  • Pacjenci z niewydolnością nerek, wątroby lub szpiku kostnego.
  • Kobiety w ciąży lub karmiące piersią.
  • Pacjenci, którzy nie mogą przyjąć podanych leków lub przejść zaplanowanych procedur.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 1, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (18)

Banner MD Anderson Cancer Center

Gilbert, United States

City of Hope

Duarte, United States

HOAG

Newport Beach, United States

UCSF

San Francisco, United States

Baptist MD Anderson Cancer Center

Jacksonville, United States

Dana-Farber Cancer Institute

Boston, United States

Cooper University Health Care

Camden, United States

Rutgers Cancer Institute

New Brunswick, United States

Atlantic Health

Summit, United States

Lenox Hill Hospital

New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, United States

Wake Forest University Health Sciences

Winston-Salem, United States

The Ohio State University Comprehensive Cancer Center

Columbus, United States

UPMC Presbyterian Hospital

Pittsburgh, United States

Vanderbilt-Ingram Cancer Center

Nashville, United States

UTHealth Houston

Houston, United States

Baylor College of Medicine

Houston, United States

The University of Texas Health Science Center at San Antonio

San Antonio, United States

Trial contact

Jana Portnow, MD

PRINCIPAL_INVESTIGATOR

Simon Khagi, MD

PRINCIPAL_INVESTIGATOR

Thomas Nelson, MD

PRINCIPAL_INVESTIGATOR

Robert Cavaliere, MD

PRINCIPAL_INVESTIGATOR

Alan Turtz, MD

PRINCIPAL_INVESTIGATOR

Morana Vojnic, MD

PRINCIPAL_INVESTIGATOR

Robert Aiken, MD

PRINCIPAL_INVESTIGATOR

John Boockvar, MD

Dominique Higgins, MD

PRINCIPAL_INVESTIGATOR

Roy E Strowd III, MD

PRINCIPAL_INVESTIGATOR

Clinical Research Coordinator

J. Bradley Elder, MD

PRINCIPAL_INVESTIGATOR

Costas Hadjipanayis, MS, MD, PhD

PRINCIPAL_INVESTIGATOR

VICC CTIP (Clinical Trials Info Program)

Ryan Merrell, MD

PRINCIPAL_INVESTIGATOR

Nitin Tandon, MD

PRINCIPAL_INVESTIGATOR

Jacob Mandel, MD

PRINCIPAL_INVESTIGATOR

Andrew Brenner, MD, PhD

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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