RecruitingPhase 2NCT06805305

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

Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma


Sponsor

Diakonos Oncology Corporation

Enrollment

180 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune therapy called DOC1021 — made from the patient's own immune cells (dendritic cells) — in adults who have just been diagnosed with glioblastoma, the most aggressive type of brain cancer. The treatment is given after surgery and alongside standard chemotherapy and radiation. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with glioblastoma and it has been confirmed by tissue analysis - Your tumor is believed to be surgically removable, and the goal is to remove at least 70% of it - You are well enough to carry out normal activities (Karnofsky score of 70 or higher) - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - Your tumor is in the lower part of the brain (infratentorial), has recurred, or has spread to the spinal fluid or outside the brain - You are pregnant or breastfeeding - You have active HIV or uncontrolled hepatitis - You have a serious autoimmune disease requiring immune-suppressing medications - You are currently in another experimental drug trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(16)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

HOAG

Newport Beach, California, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Cooper University Health Care

Camden, New Jersey, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Atlantic Health

Summit, New Jersey, United States

Lenox Hill Hospital

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

UTHealth Houston

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06805305


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