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

Exclusion Criteria

• •1. Ongoing or planned pregnancy during the whole duration of the study or lactation
• •2. 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 .
• •3. 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
• •4. 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)
• •5. History of, or current malignancy (except excised basal cell skin cancer)
• •6. Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
• •7. Primary or secondary immune deficiency disorders
• •8. Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• •9. Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
• •10. Anti-diabetic treatments other than insulin in the week prior to first study drug administration
• •11. Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
• •12. Treatment with immunotherapy within the past 3 months
• •13. Treatment with an investigational drug within the past 3 months
• •14. Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
• •15. Patients under treatment with statins at the time of screening.