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
To date, beyond surgery, there are no approved drugs and no standard of care for the treatment of FLC patients. Relapse rates after remission inducing therapies (surgery, radiation, liver transplant, systemic therapy approaches) are very high. With FusionVAC-XS15 the sponsor aims to activate the immune system specifically against the gene fusion to eradicate remaining tumor cells to improve disease remission and finally enable long-term disease-free survival. Patients with confirmed diagnosis of FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript and fulfilling the below outlined inclusion criteria will be enrolled into the clinical trial. The trial population will consist of both genders. Gender distribution in the trial is supposed to reflect the distribution in the real patient population; there will be no a priori defined quantitative ratio between females and males. FusionVAC-22 peptide will be administered subcutaneously (s.c.) with the TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51. A total of two vaccinations are planned, 4 weeks apart from each other. If no sufficient T cell response is achieved at the end of treatment visit (28 days after last vaccination) a booster vaccination at day 56 (+7 days) after the second vaccination can be applied
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
FusionVAC-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 two vaccinations are planned, 4 weeks apart from each other. If no sufficient T cell response is achieved at the end of treatment visit (28 days after last vaccination) a booster vaccination at day 56 (+7 days) after the second vaccination can be applied
University Hospital Tuebingen
Tübingen, Germany
RECRUITINGUniversitätsklinikum Tübingen, Kinderheilkunde I
Tübingen, Germany
NOT_YET_RECRUITINGEfficacy of vaccination
Primary objectives of the planned trial are to assess immunogenicity in terms of induction of peptide specific T-cell responses
Time frame: until 84 days after second vaccination
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.
Time frame: from first vaccination until 12 months after last vaccination
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