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:

• People aged 6 to 35 years old
• People who have been diagnosed with Type 1 diabetes (T1D) for fewer than 100 days at the time of joining the trial
• People who are willing to give their own consent, or, if under 18 years old, have a parent or legal guardian who is willing to give consent on their behalf
• People who have tested positive for at least one specific diabetes-related antibody (such as GAD65A, mIAA — if tested within 10 days of starting insulin — IA-2A, ICA, or ZnT8A)
• People whose pancreas is still producing a measurable level of insulin, shown by a specific test result (called a mixed meal tolerance test) taken at least 21 days after diagnosis, with the trial entry occurring within 37 days of that test
• People who test negative for a virus called Epstein-Barr virus (EBV) at screening must also have a negative EBV blood test within 30 days of joining, and must not have had EBV-like illness symptoms lasting more than 7 days in the 30 days before joining
• People who have not received a live vaccine in the last 6 weeks before joining
• People who have received a killed (inactivated) flu vaccine at least 2 weeks before joining, when that season's flu vaccine is available
• People who are willing to avoid live vaccines during the treatment period and for 3 months after the last dose of the study drug
• People who are willing to follow an intensive diabetes management plan during the trial

Who may not be able to join:

• People with a weakened immune system or with low levels of certain blood cells, including low white blood cells, low neutrophils, low lymphocytes, or low platelets
• People who have signs or symptoms of an active infection at the time of joining
• People who have had or currently have a tuberculosis (TB) infection, based on testing or medical history
• People who are currently pregnant, breastfeeding, or planning to become pregnant within the two-year study period
• People who are currently using immunosuppressive medications (drugs that suppress the immune system), including long-term use of steroid tablets or similar medicines
• People who have a current or past infection with HIV, Hepatitis B, or Hepatitis C
• People with other serious medical conditions or abnormal lab results that could interfere with the trial or pose additional health risks, including pre-existing heart disease, chronic lung disease (COPD), sickle cell disease, neurological conditions, or abnormal blood counts
• People with a history of cancer, other than certain skin cancers
• People with signs of liver problems, based on specific blood test results being significantly above normal
• People with signs of kidney problems, based on a specific blood test result being significantly above normal
• People who have received a live virus vaccine in the last 6 weeks
• People currently using non-insulin medications that affect blood sugar levels, within 7 days before screening
• People currently taking part in another Type 1 diabetes treatment study within the last 30 days
• People who have previously received any experimental treatment aimed at slowing the loss of insulin-producing cells in Type 1 diabetes
• People with a known allergy to ATG (a type of immune-suppressing medication) or Verapamil (a medication used in this trial)
• People who have previously been treated with ATG or Verapamil, or who have a known allergy to products derived from rabbits
• People with any other condition that, in the trial doctor's opinion, could negatively affect their participation or the reliability of the trial results

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