AUTOLOGOUS MATURE DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR LYSATE for Glioblastoma

Inclusion criteria

• {"criterion_text":"- Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV), including the histological variants of gliosarcoma and giant cell glioblastoma, confirmed by central neuropathologist according to the WHO classification of central nervous system tumors 2016. Tumors may cross into, but not beyond the corpus callosum.\n- Near-complete resection (≤ 5 ml residual contrast enhancing tumor volume) confirmed by central neuroradiologist on MRI scan within 72 h postoperative; awake surgery and second look surgery are possible, if medically indicated.\n- Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production."}

Exclusion criteria

• {"criterion_text":"- Severe acute or chronic medical conditions that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of trial results and, in the opinion of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to the following: Immunosuppressive disease / immunodeficiency, Chronic renal disease / failure, Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia, Severe poorly controlled diabetes, Planned other major surgery."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint is OS measured from the day of surgery until death.","definition_or_measurement_approach":"OS measured from the day of surgery until death."}

Secondary endpoints

• {"endpoint_text":"- PFS as measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria (the exact time of progression may be defined retrospectively, when pseudoprogression and pseudoresponses can be excluded definitively) or death due to any cause.","definition_or_measurement_approach":"PFS measured from the day of surgery until diagnosis of tumor progression by MRI according to modified RANO criteria or death."}
• {"endpoint_text":"- OS and PFS rates at 6, 12 and 24 months after the day of surgery.","definition_or_measurement_approach":"OS and PFS rates at 6, 12 and 24 months after the day of surgery."}
• {"endpoint_text":"- Safety based on the frequency and severity of adverse events with toxicity graded according to the NCI CTCAE version 4.03.","definition_or_measurement_approach":"Adverse events frequency and severity graded per NCI CTCAE v4.03."}
• {"endpoint_text":"- Overall and neurological performance as determined by the KPS and the MMSE-2.","definition_or_measurement_approach":"Performance assessed using KPS and MMSE-2."}
• {"endpoint_text":"- Quality of life as determined by the EORTC questionnaires QLQ-C30 version 3.0 and QLQ-BN20 as well as the DT and HADS for psycho-oncological stress assessment.","definition_or_measurement_approach":"Quality of life assessed by EORTC QLQ-C30 v3.0 and QLQ-BN20; psycho-oncological stress assessed by DT and HADS."}

Germany

Earliest CTIS Part Ii Submission Date

24-05-2024

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

504

Number Of Sites

5

Number Of Participants

136

Primary sponsor

Full Name

Heinrich-Heine-Universitaet Duesseldorf

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Bundesministerium für Bildung und Forschung (BMBF)","duties_or_roles":"Source of monetary support","organisation_type":""}