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NCT06307301Recruitment Completed

Study in ALS With Abatacept & IL-2

A Phase I Trial to Evaluate Safety and Tolerability of Abatacept Followed by Subcutaneous Interleukin-2 Administration in Patients With Amyotrophic Lateral Sclerosis
The Methodist Hospital Research InstitutePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Amyotrophic Lateral Sclerosis
Drug/Device/Intervention
Abatacept Injection [Orencia] and Proleukin (aldesleukin)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
The Methodist Hospital Research Institute
Location
Houston, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 28, 2021
End date
Oct 17, 2024
Enrollment
5 participants
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
Neuralgic amyotrophyMotor neuron diseaseOther degenerative diseases of the nervous systemOther degenerative disorders of nervous system in diseases classified elsewhereMultiple sclerosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06307301
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.