ATLG Levels in Autologous HSCT for Multiple Sclerosis

Recruiting now

Conditions studied: Multiple Sclerosis, Autologous Hematopoietic Stem Cell Transplant, ATLG

In brief

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.

Key facts

Study ID

NCT07635693

Run by

Ciceri Fabio

People needed

20

Starts

2026-05-04

Expected to finish

2029-05-04

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation in the study.
• Adult patients (age >/= 18y)
• Diagnosis of MS
• Confirmed program of autologous HSCT according to standard EBMT indications (any conditioning regimen considered standard, BEAM or Cyclophosphamide)
• ATLG (total dose 30 mg/kg over 3 days: 10 mg/kg on days -3, -2 and -1) in the conditioning regimen.

You may not qualify if…

• Subjects that did not accept to sign the informed consent.
• Use of ATG.
• Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)

Where it is running

• IRCCS Ospedale San Raffaele — Milan, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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