eligibility_summary
Adults (≥18) with chronic-phase MPN and CALR exon 9 mutation: prior/relapsed high-risk ET or low/intermediate-1 PMF/ET-MF, PS≤2, adequate organ function, FCBP negative test + dual contraception, consent, hydroxyurea stable ≥8 wks. Exclude invasive cancer <3 y (exceptions), autoimmune disease, infection, immunodeficiency, pregnancy/breastfeeding, immunosuppressants/steroids, JAK inhibitors, IFN (anagrelide ok), trial/MPN therapy, psych/medical issues, or contraception refusal.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm vaccine trial in CALR-mutant ET/MF. Interventions: 1) Mutant-CALR peptide vaccine (peptide cancer vaccine, initial dose includes KLH helper peptide) designed to present the shared 36–aa mutant CALR C-terminal neoantigen and expand CALR-specific T cells. 2) Poly-ICLC (Hiltonol), a synthetic dsRNA adjuvant and TLR3 agonist that triggers type I interferon signaling, activates dendritic cells, and enhances antigen presentation. Target cells/pathways: CALR-mutant malignant hematopoietic cells, immune activation of dendritic cells and expansion of mutant-CALR–reactive cytotoxic T lymphocytes to recognize and kill CALR+ clones.