A Phase I Trial to Evaluate Safety and Tolerability of Abatacept followed by Subcutaneous Interleukin-2 Administration in Patients with Amyotrophic Lateral Sclerosis

Investigator: Jason Thonhoff, MD

Study Coordinator: Aramide Balogun

Status: Enrolling

ClinicalTrials.gov Number: NCT99999999

Phone: 713.441.6937

Protocol Number: PRO00031998

Description

In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. We 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 4 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo.
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