Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to give their agreement to take part, or for those under 18, a parent or legal guardian must give consent on their behalf.
• People aged 8 to 45 years old at the time of signing the consent forms (note: the trial initially accepts only adults aged 18 and over, with younger participants potentially added later depending on safety reviews — confirm current age eligibility with the trial site).
• People diagnosed with Type 1 diabetes (T1D) within the last 100 days before joining the trial.
• People who test positive for at least one specific diabetes-related antibody (a sign the immune system is attacking insulin-producing cells), including certain antibodies called GAD65A, mIAA, IA-2A, ICA, or ZnT8A.
• People whose pancreas is still producing a small but measurable amount of insulin, as shown by a specific test (called an MMTT) done at least 21 days after their diabetes diagnosis.
• Adults aged 18 and over with a body weight between 35 kg and 130 kg.
• People under 18 whose body weight falls between the 5th and 98th percentile for their age and sex (a standard healthy weight range for children).
• People who are willing to follow a careful, closely monitored diabetes management plan.
• People who meet specific requirements related to two common viruses — CMV (cytomegalovirus) and EBV (Epstein-Barr virus) — including having recent negative virus tests and no related illness lasting more than 7 days in the past month (confirm exact requirements with the trial site).
• People who meet the minimum vaccination requirements set out by the TrialNet study program.
• People who have had their most recent live vaccine at least 4 weeks before joining the trial.
• People who have received a non-live flu vaccine for the current season at least 2 weeks before joining, if they have not already been vaccinated.
• People who are willing to avoid most vaccines (except for non-live flu and COVID-19 vaccines) during the treatment period and for 3 months after treatment ends.
• Females of reproductive potential who are willing to avoid becoming pregnant throughout the study, use a reliable contraceptive method or abstinence, and have pregnancy tests before each study visit.
• Males of reproductive age who are willing to use an adequate form of contraception during treatment and for 3 months after the last dose of the study drug.

Who may not be able to join:

• People whose blood test results at screening fall outside acceptable ranges for things like white blood cells, red blood cells, platelets, kidney function, liver function, or certain minerals such as potassium and sodium (confirm specific values with the trial site).
• People currently using any non-insulin medications that affect blood sugar levels within 7 days of screening, or any other medications listed as prohibited by the study.
• People currently being treated with immune-suppressing medications taken throughout the body (such as certain biologics or oral steroids) — though nasal sprays, inhalers, and eye or ear drops containing steroids are allowed.
• People showing active signs or symptoms of an infection at the time of joining the trial.
• People who have had an active infection (bacterial, viral, or fungal) requiring treatment within 4 weeks before the starting visit, unless specifically approved by the study's infectious disease committee.
• People who have evidence of a past or current tuberculosis (TB) infection, based on skin or blood tests or medical history.
• People with a current cancer diagnosis or a history of cancer in the past 5 years, except for certain types of skin cancer that have been successfully treated.
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
• People with a history of serious heart conditions, such as a heart attack, unstable heart disease, stroke, or advanced heart failure.
• People with evidence of a current or past HIV or Hepatitis B infection.
• People with evidence of an active Hepatitis C infection.
• People who have received an organ transplant.
• People with a known allergy or sensitivity to IL-2, PEG, or any ingredients in the study drug.
• People who have had major surgery within 12 weeks before screening, or who expect to need major surgery during the study.
• People with autoimmune conditions other than T1D, except for stable thyroid disease, stable asthma, inactive Graves' disease, or coeliac disease — conditions such as rheumatoid arthritis, multiple sclerosis, or lupus would likely not be eligible (confirm with trial site).
• People whose heart tracing (ECG) at screening shows signs of heart problems or abnormal heart rhythms.
• People with a history of blood clots or similar events within 6 months before joining the trial.
• People with a known but untreated significant overactive or underactive thyroid condition.
• People who have received certain immune-modifying treatments (such as teplizumab, ATG, or rituximab) within the 12 months before joining the trial.
• People who have received other treatments aimed at changing the course of T1D within 6 months before joining.
• People with any other significant uncontrolled health condition that the study doctor believes could affect their safety or the reliability of the study results.

Important: Always verify eligibility with the trial site directly before applying.