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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 21, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06529822). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 64 participants (ESTIMATED). Conditions: Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma, Melanoma, Non-small Cell Lung Cancer. Interventions: BIOLOGICAL: Synthetic long peptide personalized cancer vaccine; DRUG: Poly ICLC; DEVICE: Signatera or Altera testing. Primary outcome measures: Safety as measured by treatment-emergent adverse events (TEAEs) , From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months); Safety as measured by treatment-related adverse events (TRAEs) , From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months); Safety as measured by serious adverse events (SAEs) , From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months); Feasibility as measured by the success of enrolling patients with molecular residual disease , Through 30 months; Feasibility as measured by the expected time frame for vaccine creation , Through 24 weeks; Feasibility as measured by the rate of successful vaccine delivery , Through 1st vaccine dose (estimated to be 24 weeks). Brief summary: This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.