The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript as adjuvant treatment
Ability to understand and willingness to sign a written informed consent document.
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based NGS or RT-PCR
surgical procedures,
radiotherapy,
Pregnant or breastfeeding.
Unwilling or unable to follow the study schedule for any reason.
Concurrent or previous treatment within 14 days in another interventional clinical trial with an investigational anti-cancer treatment.
surgical procedures,
Single group
Vaccination of Fusion-VAC-XS15
DrugFusionVAC-22 peptide will be administered subcutaneously (s.c.) with the TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51 VG (1:1). A total of three vaccinations are planned, 4 weeks apart from each other.
Efficacy of vaccination
Primary objectives of the planned trial are to assess immunogenicity in terms of induction of peptide specific T-cell responses
Safety of the vaccination
Primary objective of the planned trial is to assess safety and toxicity of the peptide vaccine. The safety and toxicity of the DNAJB1-PRKACA fusion transcript-based peptide vaccine is determined based on the Common Terminology Criteria for Adverse Events (CTCAE V 5.0) and assessed in a descriptive manner.
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