DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM) (NCT06805305)
Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
๐ฉบ Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center โ Gilbert, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (18 Sites)
- Banner MD Anderson Cancer Center โ Gilbert, Arizona
- City of Hope โ Duarte, California
- HOAG โ Newport Beach, California
- UCSF โ San Francisco, California
- Baptist MD Anderson Cancer Center โ Jacksonville, Florida
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- Cooper University Health Care โ Camden, New Jersey
- Rutgers Cancer Institute โ New Brunswick, New Jersey
- Atlantic Health โ Summit, New Jersey
- Lenox Hill Hospital โ New York, New York
- UNC Lineberger Comprehensive Cancer Center โ Chapel Hill, North Carolina
- Wake Forest University Health Sciences โ Winston-Salem, North Carolina
- The Ohio State University Comprehensive Cancer Center โ Columbus, Ohio
- UPMC Presbyterian Hospital โ Pittsburgh, Pennsylvania
- Vanderbilt-Ingram Cancer Center โ Nashville, Tennessee
- UTHealth Houston โ Houston, Texas
- Baylor College of Medicine โ Houston, Texas
- The University of Texas Health Science Center at San Antonio โ San Antonio, Texas
๐ Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.