Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629274
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2020-10-29
Brief Title:
In Vitro Study of the Biological and Immunological Activity of Imotopes Candidates on Blood Cells of Patients With Stabilized NMO
Sponsor:
Imcyse SA
Organization:
Imcyse SA
Study Overview
Official Title:
IMCY-NMO-000 In Vitro Study of the Biological and Immunological Activity of Imotopes Candidates on Blood Cells of Patients With Stabilized Neuromyelitis Optica PHASE 0
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This is a fundamental prospective multi-centres interventional non-comparative study without the administration of a study product to patients
A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - ie treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease Neuromyelitis Optica Spectrum Disorders NMOSD in this study The main goal of the study will be to support the selection of Imotopes ie synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif and i capable of binding with class II HLA antigens of each patient and ii causing ex vivo the appearance of epitope -specific cytolytic CD4 T cells
A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - ie treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease Neuromyelitis Optica Spectrum Disorders NMOSD in this study The main goal of the study will be to support the selection of Imotopes ie synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif and i capable of binding with class II HLA antigens of each patient and ii causing ex vivo the appearance of epitope -specific cytolytic CD4 T cells
Detailed Description:
This is a fundamental prospective multi-centres interventional non-comparative study without the administration of a study product to patients
The objective is to test in vitro the binding of different Imotopes to class II HLA antigens on peripheral blood mononuclear cell PBMC isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease ie non-cytolytic T cells recognising the same epitopes and antigen presenting cells APC presenting the same epitopes
The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time with a minimum of 14 days interval between these 2 samples These blood samples will be taken by a member of the healthcare staff qualified to perform this type of procedure If the results obtained with the 2 initial samples would be of interest to the Sponsor the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws The total volume of blood that will be taken over a 6 months period cannot exceed 500 milliliters with a maximum of 200 milliliters over a 30-day period for patients with a weight of min 50kg The study has no other constraint
The list of analysis planned to be performed on blood samples are presented below
Identification of the class II HLA antigens of each patient
Study of the binding to HLA antigens of synthetic peptides
Identification of peptides which after binding to the HLA antigens might induce a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease ie non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes
Non selective genomic analysis SNPs in the scope of the single cell transcriptomic analysis technics
The objective is to test in vitro the binding of different Imotopes to class II HLA antigens on peripheral blood mononuclear cell PBMC isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease ie non-cytolytic T cells recognising the same epitopes and antigen presenting cells APC presenting the same epitopes
The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time with a minimum of 14 days interval between these 2 samples These blood samples will be taken by a member of the healthcare staff qualified to perform this type of procedure If the results obtained with the 2 initial samples would be of interest to the Sponsor the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws The total volume of blood that will be taken over a 6 months period cannot exceed 500 milliliters with a maximum of 200 milliliters over a 30-day period for patients with a weight of min 50kg The study has no other constraint
The list of analysis planned to be performed on blood samples are presented below
Identification of the class II HLA antigens of each patient
Study of the binding to HLA antigens of synthetic peptides
Identification of peptides which after binding to the HLA antigens might induce a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease ie non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes
Non selective genomic analysis SNPs in the scope of the single cell transcriptomic analysis technics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None