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Monoclonal Antibodies

Phase I Study in ALS with Abatacept & IL-2 for Amyotrophic Lateral Sclerosis

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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 more

Trial 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: To investigate the immunomodulatory effects of abatacept followed by IL-2, by monitoring the change in the number of Tregs 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. 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,530 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this ongoing medical study?

"The clinical trial listed on clinicaltrials.gov is presently not in search of participants. It was initially shared on 10/28/2021 and last revised on 3/5/2024. While this particular study is not actively enrolling patients, it's worth noting that there are currently 537 other trials seeking candidates for participation."

Answered by AI

Has the Phase I clinical trial for ALS using Abatacept and IL-2 received approval from the FDA?

"Given that this is a Phase 1 clinical trial investigating the safety of Abatacept & IL-2 in ALS, our team at Power rates its safety as a 1 on our internal scale. This rating reflects the limited existing data supporting both safety and efficacy at this early stage of investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study in ALS With Abatacept & IL-2

2021. "Study in ALS With Abatacept & IL-2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307301.

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