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RECRUITING
NCT06395038
PHASE1

IL-2 Plus Abatacept in FTD

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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 Our preliminary unpublished data demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in FTD patients, skewing the immune system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).

Official title: A Phase I Clinical Trial, Using Interleukin-2 (IL-2) and Abatacept in Patients with Frontotemporal Disorders

Key Details

Gender

All

Age Range

18 Years - 86 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-05-06

Completion Date

2026-04-30

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

DRUG

Abatacept plus Aldesleukin

CTLA4IgG plus Low dose Interleukin-2 (Aldesleukin) administration to modify immune responses

Locations (1)

Houston Methodist Research Institute

Houston, Texas, United States