Grafalon®therapy within 12 weeks of Type 1 diabetes (T1D) diagnosis in children and young adults to prevent the loss of residual beta cell function: a randomised, double-blind, placebo-controlled dose finding study Acronym: GIRO T1D

Prior treatment

• History of recurrent (e.g., several times a year) of severe (e.g., pneumonia) or chronic infections or conditions predisposing to chronic infections 2. History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy 3. Vaccination within 4 weeks before randomization 4. Positive Viral PCR for EBV, CMV, COVID 5. Patients with HIV or HTLV I/II infection or HepB/C 6. Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening 7. History of pancreatitis (acute or chronic) 8. Any past or current diagnosis of malignant neoplasms 9. Known impairment of the immune system, except for T1D, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease or well-balanced Hashimoto’s disease), and vitiligo 10. Patients with a psychiatric condition (e.g., severe anxiety, psychosis) that would interfere with the study as determined by the primary investigator. Stable psychiatric conditions such as chronic anxiety or depression will be allowed. 11. Patients with known allergy to one or more of the study drug components or rabbit proteins. 12. Female patients who are pregnant, lactating, or who want to get pregnant during the study period. 13. Patients with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol but excluding nicotine and caffeine). 14. Patients with any other significant chronic disease, according to the investigator discretion, exclude rare forms of diabetes (MODY) according to history and clinical judgement. 15. Obesity (BMI more than 35 kg/m2) 16. Other forms of diabetes 17. Patients unable or unwilling to comply with the protocol

• from the beginning of Screening to Visit 14.