Phase 2 Type 1 Diabetes Trial, Recruiting

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

Who might be able to join this trial:

• Adults between 18 and 65 years old.
• People who have had Type 1 diabetes for at least 5 years, with the condition first diagnosed before age 40.
• People who are able to understand and agree to take part in the study.
• People who are able to follow all study requirements, including wearing a continuous glucose monitor (a small device that tracks blood sugar levels). Note: if someone otherwise meets the study criteria but has not used one before, the trial will provide one.
• People who have been actively managed by a diabetes specialist (endocrinologist or diabetologist) with at least 4 check-up visits in the 12 months before screening, and who use an insulin pump or multiple daily insulin injections.
• People who have had at least 3 severe low blood sugar episodes in the past 12 months that were not caused by a missed meal or an insulin dosing mistake.
• People whose HbA1c (a measure of average blood sugar over time) is between 6.5% and 9.5%.
• People whose pancreas produces little to no insulin of its own, confirmed by a specific meal-based test.
• People who have reduced ability to feel or recognise when their blood sugar is getting dangerously low, confirmed by a standardised questionnaire score of 4 or more.
• Women who are surgically unable to become pregnant, or who have been through menopause for at least 2 years. Women who could potentially become pregnant may still be considered if a pregnancy blood test is negative at screening, and if they agree to use two highly effective forms of contraception throughout the study and for 90 days after the last dose of study medication.
• Men whose partners could potentially become pregnant must agree to use two highly effective forms of contraception throughout the study and for 90 days after the last dose of study medication, and must agree not to donate sperm during the study or for 90 days afterwards.
• People who test negative for COVID-19 (by PCR test) at the time of a specific treatment step in the trial.

Who may not be able to join:

• People who have previously received a transplanted solid organ (such as a kidney or liver) or a previous islet cell transplant.
• People with a body mass index (BMI) over 30 (a measure of body weight relative to height).
• People who weigh 50 kg (approximately 110 pounds) or less.
• People whose daily insulin needs are more than 1 unit per kilogram of body weight per day, or less than 15 units per day.
• People with a serious, uncontrolled form of diabetic eye disease affecting the blood vessels in the retina.
• People with high blood pressure above 140/90 mmHg.
• People whose kidneys are not functioning well enough, based on a standard blood test measurement (confirm with trial site).
• People with a high level of protein in their urine, indicating significant kidney damage.
• Women who are pregnant, breastfeeding, or unwilling to use effective contraception for the duration of the study and 90 days afterwards. Men who plan to father a child during the study or within 90 days after it ends, or who are unwilling to use effective contraception.
• People with a history of cancer, except for certain fully removed skin cancers (squamous or basal cell carcinoma).
• People with a history of blood clots, a known condition that makes blood clot too easily, or who need long-term blood-thinning medication. (People with a history of a clotted IV line who do not need long-term blood thinners may still be considered, at the lead investigator's discretion.)
• People with a known allergy to heparin (a blood-thinning medication).
• People who require long-term steroid medication for a medical condition, unless it is a low replacement dose for a condition such as Addison's disease.
• People with an active ongoing infection, including tuberculosis, HIV, hepatitis B, or hepatitis C — even if there are no obvious symptoms but blood tests show signs of infection.
• People who have had certain serious fungal infections (aspergillosis, histoplasmosis, or coccidioidomycosis) within the past year.
• People who have never been exposed to the Epstein-Barr Virus (a common virus), based on a blood test.
• People currently taking immune-suppressing medications, or who have taken certain immune-modifying drugs within the past 5 years (confirm specific drug names with trial site).
• People with persistently elevated liver enzyme levels or elevated bilirubin (a liver health marker) beyond specified limits.
• People who have previously received experimental cell or gene therapy, or who have taken part in another experimental drug study within the past 30 days (or longer, depending on the drug).
• People with a history of substance misuse within the past 6 months.
• People with an allergy to the Boost nutritional drink used in a required study test.
• People with serious heart or cardiovascular conditions, including previous stroke, a heart attack in the past 6 months, signs of reduced blood flow to the heart on testing within the last year, or significantly reduced heart pumping function.
• People with significant digestive or gastrointestinal conditions such as gallstones causing symptoms, pancreatitis, peptic ulcers, or severe ongoing diarrhoea or vomiting.
• People with high cholesterol or high triglycerides (blood fats) that remain elevated despite medical treatment, beyond specified levels.
• People with certain blood or inherited conditions that affect red blood cells or require regular blood transfusions, which could interfere with HbA1c test accuracy (confirm specific conditions with trial site).
• People with any other significant medical condition or planned surgery that the lead investigator believes could affect participant safety or the reliability of study results, or who have not followed recommended diabetes care in the past 12 months.
• People with abnormally low levels of certain blood cells (red blood cells, white blood cells, or platelets) at baseline, based on local laboratory standards. (People with low white blood cell counts may still be considered if a blood specialist clears them and the investigator determines there is no additional risk.)
• People with blood clotting problems or who require long-term blood-thinning medication after an islet cell transplant, or whose blood clotting time (INR) is above 1.5.
• People with a history of Factor V deficiency (a specific inherited blood clotting disorder).
• People who have received a live vaccine within the 2 months before screening.
• People who have previously been treated with Tegoprubart (AT-1501) or any similar medication targeting the same pathway.
• People whose immune system shows a high level of pre-existing antibodies against donor tissue (Panel-reactive Antibody above 20%), which could increase the risk of transplant rejection.
• People who test positive for COVID-19 by PCR test at a specific treatment stage of the trial.

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