Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Positive for at least one diabetes-related autoantibody any time since diagnosis, including by not limited to: Glutamate decarboxylase (GAD-65) Insulin, if obtained within 10 days of the onset of exogenous insulin therapy; IA-2; ZnT8
Peak stimulated C-peptide level ≥ 0.1 pmol/mL following a mixed meal tolerance test (MMTT) conducted within 60 days of enrollment
Females of child-bearing potential must be willing to use effective birth control and refrain from donating eggs for the purposes of assisted reproduction for duration of study.
A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening and prior to dosing.
During the study, and for 3 months after receiving the study agent, a woman must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction.
Willing and able to give informed consent for participation.

Exclusion Criteria:

History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies;
History of malignancy or serious uncontrolled cardiovascular disease or hypertension, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia despite therapy;
Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections;
History or serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C;
Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection;
Active infection with EBV ;
Active infection with CMV;
Diagnosis of liver disease or elevated hepatic enzymes, confirmed by repeat tests, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN;

Any of the following hematologic abnormalities, confirmed by repeat tests:

White blood count <3,000/μL or >14,000/μL
Lymphocyte count <500/μL
Platelet count <150,000 /μL
Hemoglobin <8.5 g/dL or > or = to 17 g/dL
Neutrophil count <2,000 cells/μL
Females who are pregnant or lactating;
Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks before treatment;
Receipt of non-live vaccine in the 4 weeks before treatment;
Any medical or psychological condition that in the opinion of the Sponsor Investigator would interfere with the safe completion of the trial;
Receipt of an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study;
Receipt of any immune-modulating biologic drug within 3 months of enrolling in the study.