This is a Phase 1/2, proof-of-principle clinical study to assess safety and efficacy of a intradermally administered tumor vaccine (MGN1601). The study will be conducted in patients with advanced renal cell carcinoma.
Twenty four patients with advanced RCC will be included in this open, single-arm study. The treatment will last 12 weeks. The investigational product (MGN1601) will be administered intradermally for a total of 8 applications, whereas the first 3 applications will be administered weekly, and the following 5 applications will be administered bi-weekly. Patients who will develop disease control (CR, PR, or SD) by week 12 will be proposed to participate in the extension phase of the study. The extension phase will be continued until disease progression in each patient, however, maximally up to week 120 (total treatment duration 2.5 years). During this time period the investigational product will be administered 5 times by weeks 24, 36, 48, 72, and 120.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Genetically modified allogeneic (human) tumor cells for the expression of IL-7, GM-CSF, CD80 and CD154, in fixed combination with a DNA-based double stem loop immunomodulator (dSLIM)
Charité - Universtitäsmedizin Berlin, Klinik für Urologie
Berlin, Germany
Universitätsklinikum Bonn, Med. Klinik und Poliklinik, Hämatologie und Onkologie
Bonn, Germany
Medizinische Hochschule Hannover, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation OE6860
Hanover, Germany
Assessment of safety profile of MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up
Assessment of potential autoimmune effects of MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up (if applicable)
Assessment of the presence of MIDGE vectors
Time frame: Treatment phase (12 weeks)
Assessment of the immune response to MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable)
Evaluation of clinical and radiological response to MGN1601
Time frame: Treatment phase (12 weeks), extension phase (120 weeks, if applicable) plus 5 years follow-up
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