Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395038
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-29
Brief Title:
IL-2 Plus Abatacept in FTD
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
A Phase I Clinical Trial Using Interleukin-2 IL-2 and Abatacept in Patients With Frontotemporal Disorders
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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Neuroinflammation is a significant component of Frontotemporal Disorder FTD Our preliminary unpublished data demonstrated that regulatory T cells Tregs have a compromised phenotype and reduced suppressive function in FTD patients skewing the immune system toward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 1MUIday 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 1MUIday every two weeks for a total of 21 weeks part 2 of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None