IL-2 Plus Abatacept in FTD

Status unconfirmed · Phase 1

Conditions studied: Frontotemporal Degeneration

In brief

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 Our preliminary unpublished data demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in FTD patients, skewing the immune system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

Key facts

Study ID: NCT06395038
Run by: The Methodist Hospital Research Institute
People needed: 10
Starts: 2024-05-06
Expected to finish: 2026-04-30
Last updated by the study team: 2025-03-10

Who can join

Age: 18 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of probable frontotemporal dementia
Male or female age 18 to 86 years
If on medications affecting cognition or behaviors (Such as Atypical Antipsychotics, Acetyl Choline Esterase inhibitors), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study. There are no prohibited medications preventing patients from participating in the study.
English language speaking
Formal education of eight or more years
Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
A family member or caretaker (study partner) who is expected to be consistently available, administer study drugs of IL-2/abatacept and attend study visits throughout the study. The study partner is also supposed to provide feedback on patient's cognitive and functional status. In the event that the designated study partner is unable to continue participating in the study, the study subject should provide another suitable study partner to ensure the uninterrupted progress of the study.
For FTD patients with limited decision-making capacity, the legally authorized representative (LAR) should be present in the decision-making process and trial participation, ensuring they understand the potential risks and benefits, and consent based on the patient's best interest. Extended time for consent will also be considered to ensure comprehension.

You may not qualify if…

Serious, active bacterial, fungal or viral infection, active or latent tuberculosis
History of severe pulmonary dysfunction
History of severe cardiac dysfunction defined as left ventricular ejection fraction <40%; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
Hypersensitivity or allergy to IL-2 or abatacept
History of bowel ischemia/perforation, or GI bleeding requiring surgery
Hospitalization or change of chronic concomitant medication within one month prior to screening.
History of hemorrhage or infarct or > 3 lacunar infarcts, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, space-occupying lesion (e.g. abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.
Clinical or laboratory findings consistent with:
Other primary degenerative dementia, (dementia with Lewy bodies, Alzheimer's disease, Huntington's disease, Jacob-Creutzfeld Disease, Down's syndrome, Parkinson's disease, etc.)
Seizure disorder
History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, Lyme disease, other laboratory values, etc.)
Clinically significant, advanced, or unstable disease that may interfere with outcome evaluations, such as:
Respiratory insufficiency
Bradycardia (<45/min.) or tachycardia (>100/min.)
Poorly managed hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg)
Uncontrolled diabetes defined by HbA1c >8%
Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) higher than two times normal
Serum creatinine higher than 2 mg/dL
Neutrophil count <1,500/mm3; platelets <100,000/mm3; hematocrit (HCT) <30%.
INR>1.4
History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, etc.).
Suspected or known allergy to any components of the study treatments.
Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.

Where it is running

Houston Methodist Research Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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