NCT06430671

Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis

Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients With Relapsing Remitting Multiple Sclerosis - RED4MS Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cellerys AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

RED4MS is a clinical trial to assess the safety and tolerability of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.

Detailed description

The RED4MS trial is designed as an open-label, dose-escalation phase Ib 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.

Conditions

• Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	CLS12311 low	Peptide-coupled Red Blood Cells (RBCs)
DRUG	CLS12311 medium	Peptide-coupled Red Blood Cells (RBCs)
DRUG	CLS12311 high	Peptide-coupled Red Blood Cells (RBCs)
DRUG	uncoupled RBCs	autologous Red Blood Cells (RBCs)

Timeline

• Start date: 2024-06-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-05-28
• Last updated: 2025-07-03

Locations

8 sites across 4 countries: Czechia, Germany, Italy, Switzerland