Early Markers of Disease and Response to Therapy

Inclusion criteria

• ≤ 7 months from type 1 diabetes diagnosis based on ADA criteria
• > 21 days from type 1 diabetes diagnosis or metabolically stable per study physician assessment
• Males and females 6-55 years of age, inclusive, at time of screening visit
• Peak MMTT stimulated C-peptide ≥ 0.2 pmol/ml
• Females of child-bearing age must be willing to use effective birth control for 1 year (which may include abstinence) from screening visit and undergo regular pregnancy testing
• Up to date for clinically recommended immunizations prior to screening
• Willing to forgo live vaccines 3 months prior to the screening visit until three months following last study drug administration
• Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age
• Weight ≥ 20 kg at baseline visit
• HbA1c ≤ 8.5% at baseline visit
• Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy)

Exclusion criteria

• Concurrent or recent (within the past 30 days of screening MMTT (visit -1)) use of non-insulin therapies aimed to control hyperglycemia
• Females who are pregnant or lactating
• Immunodeficiency or clinically significant chronic lymphopenia
• Have an active infection at time of screening or baseline visit
• Recent exposure, or possible or known active SARS-CoV-2 infection as defined by public health guidelines
• Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection
• Active infection with EBV or CMV, defined by real-time PCR
• History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac disease and stable thyroid disease
• Require use of other immunosuppressive agents for any other condition
• Use of medications known to influence glucose tolerance
• Have any complicating medical or psychological issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia).
• Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.
• Have a history of malignancies
• Receipt of live vaccine (MMR, intranasal influenza, varicella, rotatvirus) in 3 months before treatment