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.
Males or females aged ≥18 years of age
Existence of a written informed consent
Documented diagnosis of AML according to WHO guidelines
morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)
Pregnant or breastfeeding.
Unwilling or unable to follow the study schedule for any reason.
Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted).
Concurrent or previous treatment within 28 days in another interventional clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints.
Single group
Vaccines, Peptide
DrugMulti-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.
immunogenicity
Blood will be taken before peptide vaccination and during vaccination phase and follow-ups at each visit IFN-gamma ELISPOT Counts Percentage of patients with induction of an AML-VAC-XS15-specific specific T-cell response until End of study visit (EOS) compared to baseline as determined by IFNγ ELISPOT.
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This trial is not recruiting at the moment. You can still explore other options:
