Brief Summary:
A phase I-II study in patients with mutated MPN by vaccinating with PD-L1 and Aginase1 peptides with Montanide ISA-51 as adjuvant, to monitor the immunological response to vaccination and subsequently safety, toxicity and clinical effect.
Primary Purpose:Treatment
Official Title:Dual Vaccine Trial in Myeloproliferative Neoplasms
Estimated Study Completion Date :July 10, 2022
Primary Outcome Measures :
Immune response [ Time Frame: 1 year ]
T-cell cytokine release towards target antigens
Secondary Outcome Measures :
Adverse events evaluated by CTCAE v. 5.0 [ Time Frame: 1 year ]
Adverse events are graded 1-5 according to the criteria
Clinical response [ Time Frame: 10 year ]
Vaccinations will induce clinical response in 2 patients, either partial response or better, according response criteria for PV and ET or clinical response as a reduction of mutated allelic burden - 10% from baseline at any time.