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NCT04055623 · ClinicalTrials.gov registry record · Phase 2
T-regulatory Cells in ALS
A Phase 2 study, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT04055623: Active Phase 2 study, sponsored by The Methodist Hospital Research Institute.
NCT04055623 is a Phase 2 study that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055623, a Phase 2 study, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same person whose Treg were removed, given back by IV (intravenously) and in combination with low-dose IL-2 in people with Amyotrophic Lateral Sclerosis (ALS).
Primary Outcome
Change in Treg suppressive function on the proliferation of T-effector cells, as measured in percentage at baseline compared to week 24.
Interventions
- BIOLOGICAL Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
- OTHER Monthly placebo infusions + 3 times per week placebo injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04055623 still lists
NCT04055623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections is the first listed.
NCT04055623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04055623 about?
NCT04055623 is a clinical study titled "T-regulatory Cells in ALS". This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same person whose Treg were removed, given back by IV (intravenously) and in c...
What is the current status of trial NCT04055623?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-08-07. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04055623?
The interventions under investigation include: Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections (BIOLOGICAL), Monthly placebo infusions + 3 times per week placebo injections (OTHER).
Who is sponsoring clinical trial NCT04055623?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04055623's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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