Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT02035956
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2014-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IVAC MUTANOME Phase I Clinical Trial
Sponsor:
BioNTech RNA Pharmaceuticals GmbH
Organization:
Study Overview
Official Title:
First-in-human Study Evaluating the Safety, Tolerability and Immunogenicity of i.n. Administration of a Personalized Vaccination With IVAC MUTANOME Vaccine w/o Initial Treatment With RBL001/RBL002 Vaccine in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma
Detailed Description:
IVAC MUTANOME is a poly-neo-epitopic coding RNA vaccine targeting the unique mutation signature of an individual patient. It is engineered on demand, provided as two patient-specific RNA drug products and administered as an individual treatment.
RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma associated target antigens.
The two antigens are well characterized antigens in melanoma that have been previously utilized with excellent safety and proven immunogenicity as vaccine targets in a number of independent clinical trials.
The overall rationale of the study is to determine safety of the novel RNA-based vaccine strategy and determine the number and function of vaccine-induced antigen-specific immune-responses as early biomarkers for the clinical mode of action.
The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine manufactured for use in a single patient only. Parallel to the target discovery process and on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002 positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are RBL001 and RBL002 negative can also be included into the clinical study but will not receive RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing to their immunological (therapeutic) effects.
RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma associated target antigens.
The two antigens are well characterized antigens in melanoma that have been previously utilized with excellent safety and proven immunogenicity as vaccine targets in a number of independent clinical trials.
The overall rationale of the study is to determine safety of the novel RNA-based vaccine strategy and determine the number and function of vaccine-induced antigen-specific immune-responses as early biomarkers for the clinical mode of action.
The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine manufactured for use in a single patient only. Parallel to the target discovery process and on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002 positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are RBL001 and RBL002 negative can also be included into the clinical study but will not receive RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing to their immunological (therapeutic) effects.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: