Dendritic Cell Immunotherapy for Glioblastoma

Recruiting at 1 trial location

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

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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 dendritic cell immunotherapy for glioblastoma safe for humans?

Clinical trials have investigated the safety of dendritic cell immunotherapy for glioblastoma, showing that it can be safely administered to patients, although its effectiveness varies. ^{1 2 3 4 5}

How is the dendritic cell immunotherapy treatment for glioblastoma different from other treatments?

Dendritic cell immunotherapy for glioblastoma is unique because it uses the patient's own immune cells to create a personalized vaccine that targets and destroys cancer cells. This approach aims to generate a strong immune response against the tumor, which is different from traditional treatments like chemotherapy and radiation that do not specifically target cancer cells. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment DOC1021 for glioblastoma?

Research shows that dendritic cell immunotherapy, like DOC1021, has shown promising results in treating glioblastoma by helping the immune system target and destroy cancer cells. Clinical trials have demonstrated significant responses and prolonged survival in patients, with minimal side effects. ^{1 2 3 6 8}

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. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of dendritic cell vaccination for patients with recurrent glioma: results of a clinical phase I/II trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Integration of autologous dendritic cell-based immunotherapy in the standard of care treatment for patients with newly diagnosed glioblastoma: results of the HGG-2006 phase I/II trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Dendritic cell immunotherapy for brain tumors. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

The development of dendritic cell vaccine-based immunotherapies for glioblastoma. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dendritic cell immunotherapy for glioblastoma. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

Molecular subgroups and B7-H4 expression levels predict responses to dendritic cell vaccines in glioblastoma: an exploratory randomized phase II clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Dendritic cell vaccine trials in gliomas: Untangling the lines. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dendritic cell-based immunotherapy of malignant gliomas. [2019]