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New treatment option for Glioblastoma (GBM)
Official title DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
ClinicalTrials.gov ID: NCT06805305
What this study is testing
What is DOC1021?
DOC1021 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for glioblastoma (gbm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older
- Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a...
- Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1...
You likely can't join if
- Infratentorial, recurrent, leptomeningeal or extracranial disease.
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with...
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator...
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older
- Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and...
- Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3 residual CE tumor. Patients with subtotal resection will still be...
- Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is...
- Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.
- Ability to receive filgrastim (e.g., Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks.
- Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as determined appropriate for the patient by the investigator) during study treatment.
- 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 using Cockcroft and Gault for-mula: i. For males = (140 - age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL]) ii. For females = 0.85 x value from male...
- Karnofsky Performance Score ≥ 70
- Infratentorial, recurrent, leptomeningeal or extracranial disease.
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative...
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to: uncontrolled or severe cardiac disease...
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Duarte, California, United States
- Newport Beach, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
- Camden, New Jersey, United States
- New Brunswick, New Jersey, United States
- Summit, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Duarte, California, United States; Newport Beach, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.