WT1 LAMP mRNA DC for Glioblastoma (WHO grade IV)

Inclusion criteria

• {"criterion_text":"- Newly diagnosed, histologically verified glioblastoma (WHO grade IV)\n- Life expectancy ≥ 3 months as estimated by the Investigator\n- Aged ≥ 18 years\n- Total or subtotal resection: (A) Total resection = macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI \t(B) Subtotal resection = macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI\n- Signed informed consent\n- Willing and able to comply with the protocol as judged by the Investigator\n- Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection\n- Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy\n- No corticosteroid treatment ≤ 1 week before apheresis\n- WHO performance status ≤ 2"}

Exclusion criteria

• {"criterion_text":"- History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise\n- Prior radiation or chemotherapy\n- Any pre-existing contraindication for temozolomide treatment\n- Any pre-existing contraindication for contrast-enhanced brain MRI\n- Pregnant or breast-feeding\n- Documented immune deficiency or systemic immune-suppressive treatment\n- Known positive viral serology for HIV, HBV, HCV, or syphilis\n- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications"}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS) and progression-free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Feasibility will be assessed based on the number of (A) patients in the intention-to-treat (ITT) population that had a successful leukapheresis (B) patients in the ITT population that had production of qualified (phenotypic and functional requirements) vaccines (C) efficacy evaluable patients in the ITT population (D) patients with 3-weekly DC vaccine administration following chemoradiation and additional DC vaccination at day 21 of each maintenance chemotherapy cycle in the ITT population","definition_or_measurement_approach":"Feasibility assessed by counting ITT patients with successful leukapheresis, production of qualified vaccines, number of efficacy-evaluable patients, and adherence to scheduled DC vaccine administrations."}
• {"endpoint_text":"- Safety will be assessed based on adverse event frequency (scored according to the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events) in the safety population","definition_or_measurement_approach":"Safety measured by adverse event frequency graded per NCI CTCAE in the safety population."}
• {"endpoint_text":"- Immunogenicity will be assessed based on ex vivo immune responses of all patients of the immunogenicity population","definition_or_measurement_approach":"Immunogenicity assessed by ex vivo immune response measurements in the immunogenicity population (details not provided in JSON)."}

Belgium

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

449

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Antwerp University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium