CONNECT 1906: Phase 2 trial of a novel peptide vaccine (PEP-CMV) targeting CMV antigen for newly diagnosed pediatric high-grade glioma and diffuse intrinsic pontine glioma and recurrent medulloblastoma
CONNECT1906
What is the goal of the study?
Recurrent medulloblastoma (MB), diffuse intrinsic pontine glioma (DIPG), and high-grade glioma (HGG, WHO Grade 3 and 4) are responsible for the majority of brain tumor deaths in children. Patients with these tumors have limited, generally non-specific, and often toxic therapeutic options. Cytomegalovirus (CMV) antigens are ubiquitously expressed in glioblastoma (GBM) and MB. Targeting CMV antigens through peptide vaccination represents a novel and tumor-specific treatment. PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Vaccination and adoptive cellular therapy targeting CMV show promise in adults with GBM by generating anti-tumor T-cell immune responses. Lymphocyte-depleting chemotherapy such as temozolomide could diminish a host T-cell response against a brain tumor. However, somewhat paradoxically, vaccination during recovery from profound but transient lymphopenia into lymphodepleted hosts leads to dramatic in vivo T-cell expansion and potent immunologic and clinical responses to immunotherapy. We are performing a multisite, phase II clinical trial in children with recurrent MB, newly-diagnosed HGG or DIPG to determine the immunogenicity and efficacy of CMV-directed peptide vaccines.
Who can participate in the study?
Please contact the study team listed below to learn more.