A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Somaiah N, Chawla SP, Block MS, Morris JC, Do K, Kim JW, Druta M, Sankhala KK, Hwu P, Jones RL, Gnjatic S, Kim-Schulze S, Tuballes K, Yishak M, Lu H, Yakovich A, Meulen J, Chen M, Kenney RT, Bohac C, Pollack SM. A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. OncoImmunology 2020, 9: 1847846. PMID: 33312760, PMCID: PMC7714520, DOI: 10.1080/2162402x.2020.1847846.Peer-Reviewed Original ResearchConceptsNY-ESO-1Prime-boost vaccine regimenVaccine regimenImmune responseNY-ESO-1 immune responsesNY-ESO-1 antibodyNY-ESO-1 proteinToll-like receptor agonistsInjection site painOral metronomic cyclophosphamidePhase 1b studyRecombinant protein boostCommon adverse eventsDisease control ratePrime-boost vaccineT cell responsesDose-escalation designSoft tissue sarcomasLentiviral vectorsMetronomic cyclophosphamideAdverse eventsMetastatic diseaseOverall survivalProgressive diseaseStudy entry