Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes

Inclusion criteria

• Male or female 18 to 30 years of age
• Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
• Insulin requirement, as determined by the investigator
• Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
• Fasting C-peptide at screening >0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
• HLADR3-positive and/or HLADR4-positive
• Willingness to undergo the insulin treatment prescribed by the physician
• Body mass index (BMI) between 17-28 kg/m2 at screening
• Fully informed written consent obtained
• Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
• Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.

Exclusion criteria

• Ongoing or planned pregnancy during the whole duration of the study or lactation
• Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .
• Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
• Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
• History of, or current malignancy (except excised basal cell skin cancer)
• Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
• Primary or secondary immune deficiency disorders
• Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
• Anti-diabetic treatments other than insulin in the week prior to first study drug administration
• Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
• Treatment with immunotherapy within the past 3 months
• Treatment with an investigational drug within the past 3 months
• Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
• Patients under treatment with statins at the time of screening.