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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055623
The ClinicalTrials.gov registry entry for NCT04055623 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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