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NCT Number: NCT07635693

ATLG Levels in Autologous HSCT for Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis ATLG Autoimmune Diseases Autoimmune Diseases of the Nervous System Autologous Hematopoietic Stem Cell Transplant Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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).

Primary outcomes

  1. Investigate immune status in correlation with ATLG

    Time frame: before mobilization, before conditioning, +1/3/6/12 months after HSCT.

    Longitudinal IR monitoring (T/B/NK lymphocyte subpopulations including naïve- memory- stem/memory- regulatory subsets, cytokine profile, NFL/Macrophages) on PB

  2. Investigate immune status in correlation with ATLG

    Time frame: before and 30' after the end of ATLG dose, day0, day1, weekly for 4 weeks.

    Assessment of ATLG levels & kinetics

Secondary outcomes

  1. Assess clinically relevant viral infections in correlation with viral specific IR

    Time frame: before mobilization, +1 month after HSCT within the first year after HSCT.

    Assessment of pathogen-specific responses (CMV specific T cells by ELISpot) and occurrence of clinically relevant viral infections (CMV, EBV; ECIL 10 guidelines).

  2. To assess HSCT and neurological outcomes

    Time frame: at 100 days and 1-year

    Transplant-related mortality (TRM)

  3. Assessment of Progression Free Survival (PFS)

    Time frame: at 1-year

    Assessment of general HSCT outcomes (PFS)

  4. Assessment of Overall survival (OS)

    Time frame: At 1 year

    Assessment of general HSCT outcomes - OS

  5. neurological status- Expanded Disability Status Scale (EDSS)

    Time frame: at 100 days, 6 months and 1-year

    Expanded Disability Status Scale (EDSS)

  6. neurological status - neurological progression

    Time frame: at 1 year

    neurological status - neurological progression

  7. neurological status -No Evidence of Disease Activity

    Time frame: At 1 year

    No Evidence of Disease Activity (NEDA)

Study contacts

Contact information is provided by the study sponsor or research team.

Raffaella Greco

CONTACT

[email protected]

+39 02-2643-3903

Sponsors and collaborators

Lead sponsor

Ciceri Fabio

Other

Registry information

Official study title

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

Acronym: ATLG-MS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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