Treatment With hOKT3gamma1(Ala-Ala) in T1DM

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)

Criteria

Inclusion Criteria:

• diagnosed with T1DM within the past 6 weeks

• have a body weight ≥26 kg at the time of enrollment

• have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).

Exclusion Criteria:

• Pregnant or lactating females;

• Prior OKT3 treatment;

• Known hypersensitivity to murine products;

• Uncompensated heart failure or fluid overload, recent myocardial infarction;

• History of epilepsy, cancer, active infection, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease, any concurrent autoimmune diseases, asthma;

• Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial;

• Inability to give informed consent;

• Prior participation in a clinical trial that could potentially affect diabetes or immunologic status;

• Participation in a clinical trial within the last 6 weeks;

• HIV positive;

• Positive for Hepatitis B surface antigen or Anti-Hepatitis C antibody;

• Seropositivity for Toxoplasmosis (IgG);

• Lymphopenia (<1000 lymphocytes/microliter);

• Thrombocytopenia (<150,000/mm3 platelets);

• Anemia (Hgb < 10g/dL);

• Vaccination with a live virus within the past 6 weeks;

• Positive PPD skin test;

• Any infectious mononucleosis-like illness within the 3 months prior to enrollment;

• Serologic evidence of acute infection with EBV or CMV based on tests listed and as defined by the protocol.