Study in ALS With Abatacept & IL-2 - Trial NCT06307301
Access comprehensive clinical trial information for NCT06307301 through Pure Global AI's free database. This Phase 1 trial is sponsored by The Methodist Hospital Research Institute and is currently Recruitment Completed. The study focuses on Amyotrophic Lateral Sclerosis. Target enrollment is 5 participants.
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Study Focus
Abatacept Injection [Orencia] and Proleukin (aldesleukin)
Interventional
drug
Sponsor & Location
The Methodist Hospital Research Institute
Timeline & Enrollment
Phase 1
Oct 28, 2021
Oct 17, 2024
Primary Outcome
To evaluate adverse events and laboratory abnormalities to assess the safety and tolerability of abatacept followed by Interleukin 2 (IL-2) administration in ALS patients
Summary
In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg)
 numbers and suppressive function correlates with rapid disease progression. The investigator
 completed a phase 1 study of infusions of expanded autologous Tregs in combination with
 subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and
 suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with
 slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers
 and suppressive function may also stabilize disease in ALS. This phase 1 study aims to
 determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is
 safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers
 and suppressive function in vivo.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06307301
Non-Device Trial