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Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA

NCT06789198 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-12

No results posted yet for this study

Summary

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

Conditions

  • Fibrolamellar Hepatocellular Carcinoma (FLC)

Interventions

DRUG

Vaccination of Fusion-VAC-XS15

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

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789198 on ClinicalTrials.gov