RecruitingNCT07635693

ATLG Levels in Autologous HSCT for Multiple Sclerosis

ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis


Sponsor

Ciceri Fabio

Enrollment

20 participants

Start Date

May 4, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ATLG administration for people with atlg, autologous hematopoietic stem cell transplant, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATLG 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

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NCT07635693


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