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Monoclonal Antibodies
Abatacept + IL-2 for ALS
Phase 1
Waitlist Available
Led By Jason Thonhoff, MD, PhD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial aims to test a combination therapy of subcutaneous IL-2 and abatacept in ALS patients to see if it is safe and well-tolerated. The therapy aims to enhance T
Who is the study for?
This trial is for patients with ALS, a type of motor neuron disease. Participants should have a confirmed diagnosis and be in stable condition to receive injections. Specific criteria for joining or reasons one might not qualify are not provided.
What is being tested?
The study tests if combining Abatacept (Orencia) injections with Proleukin can safely increase the number and function of Tregs, immune cells that may slow ALS progression. It's an early-phase trial involving 6 patients to assess safety and effectiveness.
What are the potential side effects?
While specific side effects aren't listed, common reactions to these drugs include injection site pain, increased risk of infection, allergic reactions, and potential impact on immune system function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Change in Regulatory T cells (Tregs) numbers in the blood from baseline
Change in Regulatory T cells (Tregs) suppressive function in the blood from baseline
Changes in the level of cytokines secreted by PBMCs from baseline
Other study objectives
Changes in Amyotrophic Lateral Sclerosis functional rating scale-revised (ALSFRS-R) slope
Changes in Appel Amyotrophic Lateral Sclerosis rating scale ( AALS) slope
Changes in forced vital capacity (FVC) and maximum inspiratory pressure (MIP) scores
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Phase I Study in ALS with Abatacept & IL-2Experimental Treatment1 Intervention
Primary Objective:
1. To assess the safety and the tolerability of abatacept followed by IL-2 administration in ALS patients
Secondary Objectives:
1. To investigate the immunomodulatory effects of abatacept followed by IL-2, by monitoring the change in the number of Tregs
2. To investigate the immunomodulatory effects of abatacept followed by IL-2, by monitoring the change in the suppressive activity of Tregs on T effector proliferation.
3. To investigate the immunomodulatory effects of abatacept followed by IL-2, by monitoring in the level of cytokines secreted by PBMCs throughout the course of the study
Exploratory Objective:
1. To characterize the effects of abatacept followed by IL-2 on clinical outcome measures of ALS, including the Appel ALS Rating Scale (AALS) and ALS Functional Rating Scale-Revised (ALSFRS-R) scores, and the forced vital capacity (FVC) and maximum inspiratory pressure (MIP).
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Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
281 Previous Clinical Trials
81,601 Total Patients Enrolled
3 Trials studying Amyotrophic Lateral Sclerosis
365 Patients Enrolled for Amyotrophic Lateral Sclerosis
Jason Thonhoff, MD, PhDPrincipal InvestigatorThe Methodist Hospital Research Institute
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