Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

Inclusion Criteria: * Male and females aged 8 to 17 years of age * Diagnosis of T1DM within 100 days of receipt of study drug * Positive for at least one islet cell autoantibody * Peak MMTT-stimulated C-peptide level \> 0.2 pmol/mL (at the screening visit) * Weight of ≥30 kg * Must agree to use a reliable and acceptable method of contraception for the duration of participation * Willing and medically acceptable to postpone live vaccine immunizations for one year after infusion * Written informed consent and written assent Exclusion Criteria: * Hemoglobin less than the lower limit of normal * Leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL * Regulatory T-cells present in peripheral blood at \<20 cells per μL * Current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control) * Current or anticipated use of systemic corticosteroids or other immunomodulatory drugs * Recent serious bacterial, viral, fungal, or other opportunistic infections * History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease * Serologic evidence of current or past viral infection: human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and human T-lymphotropic virus (HTLV) 1/2 * Positive QuantiFERON® tuberculosis (TB) test, purified protein derivative (PPD) skin test, history of tuberculosis, or active TB infection * Active infection with Epstein-Barr Virus or Cytomegalovirus * Liver disease * Pregnant or breast-feeding * Vaccination with a live virus within 8 weeks of receipt of study drug * Vaccination with a killed virus within 2 weeks of receipt of study drug * Participation in an investigational drug study within 90 days prior to screening * Previously treated with a T-Reg based cell therapy * History of allergy to gentamicin