Dendritic Cell Immunotherapy for Glioblastoma

Recruiting at 8 trial locations

Overseen By Eva Schumann

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Diakonos Oncology Corporation

Must be taking: Temozolomide

Disqualifiers: Pregnancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

180 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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

I had a biopsy or partial surgery for glioblastoma without other cancer treatments.

I have signed the consent form for this trial.

I am not pregnant and agree to use birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 weeks

Regular clinic visits for treatment and assessments

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.

3 years

Regular follow-up visits

Long-term follow-up

Health-related quality of life is assessed over a 5-year period using EORTC Quality of Life Questionnaire.

5 years

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?

Group I: DOC1021 + pIFN + SOC Experimental Treatment 4 Interventions

DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment

Group II: SOC Active Control 3 Interventions

Standard of Care treatment alone

Who Is Running the Clinical Trial?

Diakonos Oncology Corporation

Lead Sponsor

Trials

1

Recruited

140+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06805305

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 ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2014

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 ...

4. cgtlive.com cgtlive.com/view/evaluating-immunotherapy-doc1021-glioblastoma

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 ...

5. prnewswire.com prnewswire.com/news-releases/diakonos-oncology-presents-promising-preliminary-data-from-phase-1-study-of-doc1021-cell-based-immunotherapy-in-pancreatic-cancer-at-society-for-immunotherapy-of-cancer-40th-annual-meeting-302608210.html

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.pdf

DOC1021 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.

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000211043

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 ...