Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients — AML-VAC-XS15  

Acute Myeloid Leukemia, Adult Clinical Trial

Official title: Multi-peptide Vaccination Adjuvanted With the TLR1/2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy

Status Not yet recruiting

Clinical Trial Summary

The aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.

Clinical Trial Description

Peptide vaccine: Multi-peptide vaccine cocktail comprising 9 different immunopeptidome-defined mutated and non-mutated AML/ leukemia stem and progenitor cell (LSC)-associated HLA class I and HLA class II peptides.

The vaccine cocktail is synthesized and formulated in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen (headed by Juliane Walz).

Treatment schedule:

The vaccine cocktail will be administered subcutaneously (s.c.) together with the (toll-like receptor )TLR1/2 ligand XS15 (50 µg) emulsified in Montanide ISA 51 VG (1:1) as adjuvant.

Two vaccinations within a 6-week interval are planned, with the option of one additional booster in case of insufficient response after the first two vaccinations.

Peptide vaccination will take place in AML patients that have achieved a morphological complete remission (CR) or a complete remission with incomplete blood count recovery (CRi) with standard first line treatment. Minimal residual disease (MRD) positivity is permitted.

Vaccination will start 4-28 weeks after last application of intensive chemotherapy). Any maintenance treatment, e.g. with oral azacytidine or midostaurin, or ongoing low intensity therapy, e.g. with HMA, venetoclax etc. is permitted, can be applied throughout the vaccination and continued after study treatment according to the treating physician's decision. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT06252584
• Study type: Interventional
• Source: University Hospital Tuebingen
• Contact: Juliane Walz, Prof. Dr.
• Phone: +49 7071 29
• Email: kketi@med.uni-tuebingen.de
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2, 2024
• Completion date: November 2, 2026