Dendritic Cell Immunotherapy for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals recently diagnosed with glioblastoma, a type of brain cancer. Researchers aim to determine if adding DOC1021 (a dendritic cell immunotherapy) and pIFN to standard care can extend patients' lives and ensure safety. The trial includes two groups: one receives the new treatment with standard care, while the other receives only standard care. Suitable candidates for this trial are those with a recent glioblastoma diagnosis who plan to undergo surgery and can receive follow-up treatments like chemotherapy and radiation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in glioblastoma care.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that DOC1021 has potential based on earlier studies. In previous trials, patients who took DOC1021 reported no major safety issues. The treatment was generally well-tolerated, with only mild side effects such as tiredness and minor reactions at the injection site. These results suggest that DOC1021 might be safe for humans. However, as this trial continues to collect safety information, there may be more to learn. Participants considering this trial should feel reassured that DOC1021 has shown promise in earlier studies.12345
Why do researchers think this study treatment might be promising for glioblastoma?
Researchers are excited about DOC1021 because it represents a novel approach to treating glioblastoma, a particularly aggressive brain cancer. Unlike standard treatments like surgery, radiation, and chemotherapy, DOC1021 harnesses dendritic cell immunotherapy, which aims to boost the body’s own immune response against cancer cells. Additionally, this treatment is administered by injection near deep-cervical lymph nodes, potentially enhancing its effectiveness by targeting immune system hubs directly. The combination with pIFN, an adjuvant, could further amplify the immune system's ability to fight the tumor, offering hope for improved outcomes compared to conventional methods.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
Research has shown that DOC1021, a treatment using the body's immune cells, may help treat glioblastoma, a type of brain cancer. Participants in this trial will receive either DOC1021 combined with pIFN and standard of care (SOC) treatment or SOC treatment alone. In earlier studies, 88% of patients who received DOC1021 lived for at least 12 months, compared to about 60% of those who received only the usual treatment. Additionally, those treated with DOC1021 lived an average of 19.7 months, longer than the typical 12.7 months. This treatment boosts the immune system to help fight the tumor. Overall, DOC1021 appears to improve both the lifespan and survival chances of glioblastoma patients.14567
Are You a Good Fit for This Trial?
Adults diagnosed with a specific brain cancer called glioblastoma (IDH-wt) who haven't had other cancer treatments and are good candidates for surgery, chemotherapy, and radiation. They must be willing to follow the study plan and be available throughout the trial. Women of childbearing age need a negative pregnancy test and must use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DOC1021 + pIFN alongside standard of care, including surgery, temozolomide chemotherapy, and radiation. DOC1021 injections every 2 weeks for 3 doses and pIFN injections weekly for 6 doses.
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment. Survival rates are assessed at 1, 2, and 3 years post-diagnosis.
Long-term follow-up
Health-related quality of life is assessed over a 5-year period using EORTC Quality of Life Questionnaire.
What Are the Treatments Tested in This Trial?
Interventions
- DOC1021
Trial Overview
The trial is testing if adding DOC1021 dendritic cell immunotherapy plus pIFN to standard care improves survival in glioblastoma patients. Participants will receive injections of DOC1021, pIFN shots, filgrastim doses, leukapheresis collection, alongside regular treatment including surgery, Temodar chemo, and radiation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
Standard of Care treatment alone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Diakonos Oncology Corporation
Lead Sponsor
Citations
Study Details | NCT06805305 | DOC1021 Dendritic Cell ...
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 ...
2.
diakonosoncology.com
diakonosoncology.com/news/cns-2024-conference-presentation-diakonos-oncologys-autologous-dendritic-cell-vaccine-doc1021-yields-93-12-month-survival-for-glioblastoma-patients/Diakonos Oncology's Autologous Dendritic Cell Vaccine ...
KM-projected overall survival is currently 19.7 months as compared to the 12.7 months survival expected in unmethylated GBM patients receiving ...
Vaccination for Glioblastoma: Phase I Trial Results
OS at 12-months was 88% compared to expected ~60% for SOC and 5 patients are still alive at 19-30 months of follow-up. Two recurrent ...
Evaluating Immunotherapy DOC1021 for Glioblastoma
The dendritic cells are able to really potently stimulate a Th1 T-cell response, which we know is not as effective if the cells are only loaded ...
Diakonos Oncology Presents Promising Preliminary Data ...
The treatment was well tolerated, with no dose-limiting toxicities observed. Favorable biomarker signatures and a promising survival signal were ...
6.
diakonosoncology.com
diakonosoncology.com/wp-content/uploads/2024/12/SNO-Vaccine-talk_19Nov2024updated.pdfDOC1021 Cell-Based Vaccination as Adjuvant Therapy for ...
DOC1021 is a unique homologous double-loaded. DC vaccine, using tumor-lysate and mRNA o Leverages p38MAPK and mTORC1 signaling cascades to initiate.
Phase I Analysis of DOC1021, A Cell-based Vaccination ...
We report ongoing results of an open-label phase I trial in which DC vaccines prepared through homologous antigenic loading were administered to patients with ...
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