Clinical trial 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 dendritic cell vaccine being studied as a potential treatment for newly diagnosed glioblastoma (IDH-wt). DOC1021 is designed to train the patient's immune system by presenting tumor antigens on dendritic cells to stimulate an anti‑tumor immune response.
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
- This study is testing whether adding a new immune therapy to standard care helps people live longer. It also checks how safe the new treatment is.
- Who it's for
- You may be able to join if you are an adult with newly diagnosed glioblastoma.
- What's involved
- You would get standard surgery, chemo, and radiation. You might also get blood draws and special cell injections.
- Time commitment
- You would visit the clinic regularly for check-ups and treatments.
- 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.
- 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.
- Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization.
- 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.
- 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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.