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ATLG Levels in Autologous HSCT for Multiple Sclerosis
Sponsor: Ciceri Fabio
Summary
This is a prospective, observational, biological, multicenter study to investigate IR profile, ATLG dynamics, main HSCT and disease outcomes in MS. This study will provide a preliminary descriptive evaluation of key study parameters, including ATLG pharmacokinetics and immune reconstitution trends, as well as an initial assessment of variability (e.g., dispersion of immunological biomarkers), to support the interpretation of results and the design of future studies. Since this is an observational study, no clinical decision will be made, and the interim analysis will not have an impact of the study conduction, and it will not be a stopping rule.
Official title: ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-05-04
Completion Date
2029-05-04
Last Updated
2026-06-09
Healthy Volunteers
No
Interventions
ATLG administration
Patients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1).
Locations (1)
IRCCS Ospedale San Raffaele
Milan, Italy, Italy