Study in ALS With Abatacept & IL-2 (NCT06307301) | Clinical Trial Compass
CompletedPhase 1
Study in ALS With Abatacept & IL-2
United States5 participantsStarted 2021-10-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provided informed consent and authorized use of protected health information (PHI) in accordance with national and local patient privacy regulations.
✓. ALS meeting El Escorial criteria for possible, probable, lab-supported probable, or definite ALS.
✓. At least 18 years old.
✓. Total bilirubin less than or equal to 1.5 mg/dL
✓. Alanine aminotransferase level (ALT) less than or equal to five times normal, albumin greater than or equal to 3.0 gm/dL
✓. Serum creatinine less than 1.5 mg/dL
✓. Capable of complying with all study procedures, including the study drug delivery procedure, in the Investigator's opinion.
✓. A family member or caretaker who is expected to be consistently available to administer both study drugs of abatacept and IL-2 if the participant is unable to do so.
Exclusion criteria
✕. Serious, active bacterial, fungal, or viral infection, active or latent tuberculosis.
What they're measuring
1
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
✕. Severe cardiac dysfunction defined as left ventricular ejection fraction \<40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months.
✕. Hypersensitivity or allergy to IL-2 or abatacept.
✕. History of bowel ischemia/perforation, or GI bleeding requiring surgery.
✕. History of resistant seizures, history of coma or toxic psychosis lasting \>48 hours.
✕. Platelets \<100,000/mm3; hematocrit \<30%.
✕. History of cancer in the past 5 years (except cutaneous Basal cell carcinoma or squamous cell carcinoma).