A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in patients with clinical recent-onset Type 1 Diabetes Mellitus (T1D)

Intrexon T1D Partners, LLC (IT1D)0 sites48 target enrollmentStarted: May 30, 2018Last updated: November 22, 2021

Overview

No summary available.

•\- Male or non\-pregnant, non\-lactating females, 18\-40 years of age (both inclusive) or 12\-17 years of age (both inclusive)
•\- Diagnosis of diabetes according to the ADA recommended criteria
•\- Evidence of auto\-antibodies to at least 1 of the following ß\-cell autoantigens: insulin, IA\-2, GAD65, ZnT8
•\- Stimulated C\-peptide measured during 4h Mixed Meal tolerance Test (MMTT) \> 0\.2 nmol/L
•\- The first administration of AG019 should occur no later than 150 days post diagnosis
•\- Body weight \= 33kg
•\- Willing and medically able to postpone live vaccine immunizations for at least 8 weeks after randomization
•\- Ability and willingness of patients to participate fully in all aspects of this clinical study
•\- Written informed consent obtained and documented
•\- Willingness to use a continuous glucose monitoring device and willingness to comply with the protocol defined glucose monitoring

•\- Previous history of serious cytokine release syndrome to teplizumab or other humanized anti\-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors
•\- Current use of any systemic antibiotics, except for the following: metronidazole (metronidazole), nalidixic acid (first generation quinolone), trimethoprim, sulfamethoxazole (sulfonamide) and/or a combination of both in a ratio 1/19 (sulfonamides)
•\- Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization
•\- Participation in another investigational drug trial within 12 weeks prior to the first study drug intake and during participation in this study
•\- History of recurrent infections, other autoimmune diseases, cardiac disease, malignancy, or any other (chronic) medical condition which, in the investigator’s opinion, could compromise participant safety
•\- Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C (HCV), Hepatitis Virus Type B (HBV) infection
•\- Evidence of active infection with Epstein\-Barr Virus (EBV) or cytomegalovirus (CMV)
•\- Untreated hypothyroidism or active Graves’ disease
•\- Evidence of any active infection with the exception of superficial skin infections
•\- Vaccination with live virus or organism within 8 weeks prior to randomization

Sponsor

Intrexon T1D Partners, LLC (IT1D)