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

Conditions

• Glioblastoma (GBM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DOC1021 — BIOLOGICAL
  Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
• Tumor resection — PROCEDURE
  SOC brain tumor resection
• Temodar (Temozolomide) — DRUG
  SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
• SOC cranial radiation — RADIATION
  60Gy radiation over 6 weeks in 2Gy fractions

Study Details

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

Key Dates

Start date

Mar 17, 2025

Status verified

Apr 2026

Primary completion

Mar 31, 2030

Completion

Mar 31, 2032

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DOC1021 + pIFN + SOC
  DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
• Active Comparator: SOC
  Standard of Care treatment alone

Primary Outcome Measure

Overall survival (time in months from randomization until death for each participant) [ Time Frame: 5 years ]

Locations (16)

Find similar trials in Gilbert, AZ

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