Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430671
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-06
Brief Title:
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
Sponsor:
Cellerys AG
Organization:
Cellerys AG
Study Overview
Official Title:
Multicenter Phase IbIIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial
Status:
RECRUITING
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:
RED4MS
Brief Summary:
RED4MS is a clinical trial to assess the safety tolerability and efficacy of autologous peptide coupled red blood cells CLS12311 in patients with relapsing remitting multiple sclerosis RRMS CLS12311 consists of autologous red blood cells RBCs chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance
Detailed Description:
The RED4MS trial is designed as a combination of a phase Ib part A and a phase IIa part B study
Part A is an open-label dose-escalation study enrolling 9 RRMS patients in three ascending dose groups The first patient sentinel in each dose group will receive one cycle of the therapy while the remaining patients will receive two treatment cycles
Part B is a baseline-to-treatment dose-blinded randomized study and is designed to test the safety and efficacy of three different doses of CLS12311 During baseline phase a total of 45 patients with active disease on magnetic resonance imaging MRI will be selected for the treatment phase and randomized in a 111 ratio into one of three dosing groups Each patient will receive two cycles of therapy
Part A is an open-label dose-escalation study enrolling 9 RRMS patients in three ascending dose groups The first patient sentinel in each dose group will receive one cycle of the therapy while the remaining patients will receive two treatment cycles
Part B is a baseline-to-treatment dose-blinded randomized study and is designed to test the safety and efficacy of three different doses of CLS12311 During baseline phase a total of 45 patients with active disease on magnetic resonance imaging MRI will be selected for the treatment phase and randomized in a 111 ratio into one of three dosing groups Each patient will receive two cycles of therapy
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