Frontotemporal DegenerationPhase 1NCT06395038
IL-2 Plus Abatacept in FTD
A Phase 1 study testing Abatacept plus Aldesleukin in people with Frontotemporal Degeneration, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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 Our preliminary unpublished data demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in FTD patients, skewing the immune system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… Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Frontotemporal Degeneration
- What is being tested?
- Abatacept plus Aldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
- Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.
- Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR >1.4 or other coagulopathy; platelet count of <100,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.
- Known to be pregnant or lactating, or positive pregnancy test at screening ; This study allows enrolling women of childbearing potential and the treatments may involve unknown risks to the fetus if pregnancy were to occur during the study. This risk is mitigated by requiring proof the participant is not pregnant prior to start of treatment and requiring highly effective contraception during and, for an appropriate interval, after treatment.
- Lack of reliable study partner.
Trial locations and contacts
1 site in 1 country.
Maria B Pascual contact
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Alireza Faridar, 7134411150, afaridar@houstonmethodist.org
Maria B Pascual, bpascual@houstonmethodist.org
About this study
Official title: A Phase I Clinical Trial, Using Interleukin-2 (IL-2) and Abatacept in Patients with Frontotemporal Disorders
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
- Frontotemporal Degeneration
- Being tested
- Abatacept plus Aldesleukin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept plus AldesleukinDrug
CTLA4IgG plus Low dose Interleukin-2 (Aldesleukin) administration to modify immune responses
| Study group | Role | What they receive |
|---|---|---|
| Abatacept plus Aldesleukin every 4 weeks | Active comparator | Subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every four weeks will be administered for a total of 21 weeks Receives: Drug: Abatacept plus Aldesleukin |
| Abatacept plus Aldesleukin every 2 weeks | Active comparator | Subcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every two weeks will be administered for a total of 21 weeks Receives: Drug: Abatacept plus Aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and the tolerability of abatacept plus IL-2 in FTD patients
Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).
Measured: 6 months treatment phase
Secondary outcomes (1)
To investigate the impact of low dose IL-2 plus abatacept administration on the blood Treg population in FTD patients
Change in Treg percentage out of total # of CD4 cells from baseline to month 6
Measured: 6 months treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start6 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DegenerationStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Faridar, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395038
- Sponsor's protocol ID
- PRO00037661
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial, Using Interleukin-2 (IL-2) and Abatacept in Patients with Frontotemporal Disorders
- ClinicalTrials.gov ID
- NCT06395038
- Acronym / sponsor ID
- PRO00037661
- Conditions
- Frontotemporal Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept plus Aldesleukin every 4 weeks | Active comparator | Drug: Abatacept plus AldesleukinSubcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every four weeks will be administered for a total of 21 weeks |
| Abatacept plus Aldesleukin every 2 weeks | Active comparator | Drug: Abatacept plus AldesleukinSubcutaneous abatacept (125 mg) followed by five-day-courses of IL-2 (1MUI/day) every two weeks will be administered for a total of 21 weeks |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept plus AldesleukinCTLA4IgG plus Low dose Interleukin-2 (Aldesleukin) administration to modify immune responses | Drug | Abatacept plus Aldesleukin every 2 weeks, Abatacept plus Aldesleukin every 4 weeks |
Primary outcome
To assess the safety and the tolerability of abatacept plus IL-2 in FTD patients
Time frame: 6 months treatment phase
Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology).
1 secondary outcome
To investigate the impact of low dose IL-2 plus abatacept administration on the blood Treg population in FTD patients
Time frame: 6 months treatment phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria B Pascual contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept plus Aldesleukin in people with Frontotemporal Degeneration, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Faridar (2814131431, faridar99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and the tolerability of abatacept plus IL-2 in FTD patients (time frame: 6 months treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.