Immunotherapy using patient-derived dendritic cells for glioblastoma treatment

Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (DENDR1)

This study is testing a new immunotherapy using patients' own immune cells to see if it can help people with newly diagnosed glioblastoma after they have surgery, radiation, and chemotherapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Milano)
• Trial ID: NCT04801147 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of autologous tumor lysate-loaded dendritic cells as an immunotherapy approach for patients with newly diagnosed glioblastoma multiforme. The treatment protocol includes radical surgical resection of the tumor, followed by radiotherapy and chemotherapy, after which patients will receive a series of dendritic cell vaccinations designed to stimulate an immune response against residual tumor cells. The trial aims to evaluate the safety and efficacy of this innovative immunotherapy in conjunction with standard treatment protocols.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a first diagnosis of glioblastoma and a Karnofsky Performance Status of 70 or higher.

Not a fit: Patients who are pregnant, have acute infections requiring treatment, or are participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective long-term treatment option for glioblastoma patients, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies using dendritic cell immunotherapy for glioblastoma have shown promise, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years and ≤70 years.
* Postoperative Karnofsky Performance Status ≥70.
* First diagnosis of GBM (World Health Organization \[WHO\] grade IV astrocytoma).
* Diagnosis confirmed by the reference histopathology.
* Residual tumor volume after resection \<10 cc, confirmed by postoperative MRI assessment
* Total or subtotal resection of tumor mass, confirmed by assessment of the neurosurgeon and by postoperative radiological assessment.
* Amount of non-necrotic tissue for lysate preparation and DC loading ≥1 gr, stored at -80°C.
* Corticosteroids daily dose ≤4 mg during the 2 days prior to leukapheresis.
* Clinical indication for radiochemotherapy according to the Stupp protocol (Stupp et al., 2005).
* Life expectancy \> 3 months.
* Informed consent

Exclusion Criteria:

* Pregnancy.
* Participation in other clinical trials with experimental drugs simultaneously or within 1 month before this trial entry.
* Presence of acute infection requiring active treatment.
* Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose.
* Presence of sub-ependymal diffusion of the tumor.
* Presence of multi-focal GBM lesions.
* Haematology: leukocytes \< 3,000/μl, lymphocytes \< 500/μl, neutrophils \< 1,000/μl, hemoglobin \<9 g/100 ml, thrombocytes \< 100,000/μl one or two days prior to leukapheresis.
* Documented immune deficiency.
* Documented autoimmune disease.
* Positive serology for HIV, HBs antigen, HCV, TPHA.
* Allergies to any component of the DC vaccine.
* Known intolerance to TMZ.
* Other active malignancy.

Where this trial is running

Milano

• UOC Neuro-oncologia Molecolare — Milano, Italy (Recruiting)

Study contacts

• Study coordinator: Marica Eoli, MD

Conditions Glioblastoma