Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The Lipo-MERIT vaccine consists of the four naked ribonucleic acid (RNA)-drug products (DPs) RBL001.1, RBL002.2, RBL003.1, and RBL004.1 that are optimised to induce antigen-specific CD8+ and CD4+ T cell responses against four selected malignant melanoma-associated antigens respectively. In this stud...
The Lipo-MERIT vaccine consists of the four naked ribonucleic acid (RNA)-drug products (DPs) RBL001.1, RBL002.2, RBL003.1, and RBL004.1 that are optimised to induce antigen-specific CD8+ and CD4+ T cell responses against four selected malignant melanoma-associated antigens respectively. In this study, naked RNA DPs will be formulated with liposomes to form RNA-lipoplexes (RNA(LIP)) that (i) protect RNA from degradation in the serum, (ii) enable in vivo targeting of systemic antigen-presenting cells (APC), and therefore (iii) constitute a novel vaccine formulation that supports intravenous administration. The Lipo-MERIT vaccine is expected to lead to several effects contributing to its immunological (therapeutic) effect. First, the RNA-lipoplexes home to APCs in lymphoid organs after intravenous injection, where they are rapidly taken up by professional APCs. Incorporated RNA is translocated to the cytoplasm leading to its translation by the host ribosome complex into four Antigen encoding proteins which are processed and presented on both HLA-class I as well as HLA-class II molecules. Consecutively, antigen-specific CD8+ and CD4+ T cell responses will be triggered by HLA-peptide complexes on the surface of antigen-presenting cells. In addition, the Lipo-MERIT vaccine is expected to transiently activate APCs (change of surface marker expression and cytokine secretion) via signalling of TLRs, subsequently leading to the transient induction of inflammatory cytokines (such as IFN-α and IP-10) supporting the induction of tumour-antigen specific T cell responses.
Tracking Information
- NCT #
- NCT02410733
- Collaborators
- Not Provided
- Investigators
- Study Director: BioNTech Responsible Person BioNTech SE
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