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NCT06307301 · ClinicalTrials.gov registry record · Phase 1
Study in ALS With Abatacept & IL-2
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT06307301 is a Phase 1 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 5 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06307301, a Phase 1 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Abatacept Injection [Orencia] and Proleukin (aldesleukin)
Study Locations (1)
Texas
- Houston Methodist Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06307301
The ClinicalTrials.gov registry entry for NCT06307301 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Abatacept Injection [Orencia] and Proleukin (aldesleukin) is the first listed.
NCT06307301 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06307301 about?
NCT06307301 is a clinical study titled "Study in ALS With Abatacept & IL-2". 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...
What is the current status of trial NCT06307301?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-10-28. Estimated completion is 2024-10-17.
What conditions does trial NCT06307301 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT06307301?
The interventions under investigation include: Abatacept Injection [Orencia] and Proleukin (aldesleukin) (DRUG).
Who is sponsoring clinical trial NCT06307301?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06307301 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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