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NCT06395038 · ClinicalTrials.gov registry record · Phase 1
IL-2 Plus Abatacept in FTD
A Phase 1 study of Frontotemporal Degeneration, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06395038 is a Phase 1 study of Frontotemporal Degeneration that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06395038, a Phase 1 study of Frontotemporal Degeneration, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Neuroinflammation is a significant component of Frontotemporal Disorder (FTD). Our preliminary unpublished data demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in FTD patients, skewing the immune system toward a proinflammatory status and potentially contributing to disease progression. Low dose interleukin-2 (IL-2) is now viewed as a very promising immunoregulatory drug with the capacity to selectively expand and restore functional Tregs. Our preclinical data also demonstrated synergistic effect of interleukin-2 and abatacept (CTLA4-IgG) in remodeling immunologic pathways. Abatacept is an FDA approved medication that has been indicated as a monotherapy or concomitantly with other anti-inflammatory drugs to modulate inflammation in autoimmune disorders. This study is a phase I, open-label study to assess safety and tolerability of low dose IL-2 plus abatacept immunotherapy in FTD individuals. In the first part of this study, 5 FTD patients will be recruited. These five individuals will receive subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every four weeks for a total of 21 weeks (part-1 of the study). If the treatment strategy is safe and well-tolerated, up to 5 additional FTD subjects will be recruited to receive subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every two weeks for a total of 21 weeks (part 2 of the study).
Conditions Studied
Interventions
- DRUG Abatacept plus Aldesleukin
Study Locations (1)
Texas
- Houston Methodist Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-05-06 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06395038
The ClinicalTrials.gov registry entry for NCT06395038 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 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 1 condition, with Frontotemporal Degeneration appearing as the primary indexed condition, and to 1 intervention - of which Abatacept plus Aldesleukin is the first listed.
NCT06395038 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06395038 about?
NCT06395038 is a clinical study titled "IL-2 Plus Abatacept in FTD". Neuroinflammation is a significant component of Frontotemporal Disorder (FTD). Our preliminary unpublished data demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in FTD patients, skewing the immune system toward a proinflammatory status and po...
What is the current status of trial NCT06395038?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-05-06. Estimated completion is 2026-04-30.
What conditions does trial NCT06395038 study?
This clinical trial studies the following conditions: Frontotemporal Degeneration.
What interventions are being tested in trial NCT06395038?
The interventions under investigation include: Abatacept plus Aldesleukin (DRUG).
Who is sponsoring clinical trial NCT06395038?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06395038 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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