Immuun interventie met tolerogene dendritische cellen (DC) in type 1 diabetes. Eerste klinische veiligheidsstudie genaamd D-sense

• Age 18-50 years;

• Diagnosis of type 1 Diabetes Mellitus at least 18 months (dated from the first insulin injection);

• Adequate self-assessment of blood glucose values, and recording of glucose values and administered insuline
doses as deemed sufficient by the patient¡¯s physician

• Stable glycemic control according to the patient¡¯s physician

• Possession of *0401 allele at the HLA-DRB1 gene locus;

• Written and witnessed informed consent.

• Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to
enrolment and/or prior monoclonal antibody therapy of any type given for any indication at any time;

• Immunisation with live or killed vaccines or allergic desensitization procedures less than 1 month prior to
enrolment;

• History of disease associated with autoimmunity or inflammatory disorders other than type 1 Diabetes Mellitus;

• History of malignancy;

• Male or female patients who are fertile and are unwilling to use adequate contraception at least 3 months prior to
the first administration of PIpepTolDCs until at least 60 days following the last administration of PIpepTolDCs;

• Recent (< 3 months) fasting insulin C-peptide > 200 pmol/L;

• Peak insulin C-peptide < 200 pmol/L after stimulation with Mixed Meal Tolerance Tests (MMTT).

• Recent (< 3 months) HbA1c > 64 mmol/ mol.

• No positive beta-cell autoantibody or antibodies (eligible autoantibodies: anti IAA, GADA or dIA-2A)

• Female patients who are pregnant or breastfeeding;