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OncoMatch/Clinical Trials/NCT06805305

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

Is NCT06805305 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including DOC1021 and Temodar (Temozolomide) for glioblastoma (gbm).

Phase 2RecruitingDiakonos Oncology CorporationNCT06805305Data as of May 2026

Treatment: DOC1021 · Temodar (Temozolomide)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

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-cancer treatment for glioblastoma

Exception: prior biopsy or subtotal resection allowed if no other anti-cancer treatment received for glioblastoma and additional resection indicated

Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.

Cannot have received: investigational drug or other experimental intervention

Treatment with another investigational drug or other experimental intervention within the last 30 days.

Lab requirements

Blood counts

Hemoglobin ≥ 8.0 gm/dL; ANC ≥ 1,500 cells/mm3; Platelet count ≥ 75,000/mm3

Kidney function

Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault formula

Liver function

Total bilirubin ≤ 1.5x ULN (≤ 2x ULN for Gilbert's disease); AST and ALT ≤ 3x ULN

Adequate kidney, liver, bone marrow function, and immune function, as follows: Hemoglobin ≥ 8.0 gm/dL; Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelet count ≥ 75,000/mm3; Calculated creatinine clearance (CrCl) > 30 mL/min...Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 2 times ULN; AST (SGOT) and ALT (SGPT) ≤ 3 times the ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • City of Hope · Duarte, California
  • HOAG · Newport Beach, California
  • Baptist MD Anderson Cancer Center · Jacksonville, Florida
  • Cooper University Health Care · Camden, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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