ATLG Levels in Autologous HSCT for Multiple Sclerosis

Sponsor
Ciceri Fabio
Study ID
NCT07635693
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATLG administration — DRUG
    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).

Study Details

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 Dates

First listed
Jun 9, 2026
Start date
May 4, 2026
Status verified
Jun 2026
Primary completion
May 4, 2028
Completion
May 4, 2029

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Multiple Sclerosis patients treated with autologous HSCT as standard of care
    The study will involve 20 Multiple Sclerosis (MS) patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous Hematopoietic stem cell transplantation (HSCT) is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy Disease modifying therapies (DMTs) or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.

Primary Outcome Measure

Investigate immune status in correlation with ATLG [ Time Frame: before mobilization, before conditioning, +1/3/6/12 months after HSCT. ]

Central Contacts

Find similar trials

Nationwide
Multiple sclerosis trialsNeurology trialsBrain disorders trialsAutoimmune disease trials

Related Studies