A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of 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 in Patients With Advanced Renal Cell Carcinoma (ASET Study)
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of safety profile of MGN1601
Treatment phase (12 weeks), extension phase (120 weeks, if applicable), plus 5 years follow-up
Steffen Weikert, PD Dr.
Charité - Universtitäsmedizin Berlin, Klinik für Urologie