A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diabetes type1

In brief

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).

Key facts

Study ID

NCT03751007

Run by

Precigen Actobio T1D, LLC

People needed

45

Starts

2018-10-24

Expected to finish

2021-10-13

Last updated by the study team

2023-02-01

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 American Diabetes Association (ADA) recommended criteria
• Evidence of auto-antibodies to at least 1 β-cell autoantigen
• 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 of diabetes
• Body weight ≥ 33kg
• Written informed consent obtained and documented (participant, parent, guardian as applicable)

You may not qualify if…

• 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. (Participants enrolled in the second phase of the trial in either Combination Cohort 1 or Combination Cohort 2, only)
• 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)
• Evidence of active or latent tuberculosis (TB)
• Administration of anti-CD3 antibody in past year
• Current therapy with any other anti-diabetic agents other than insulin (MDI, CSII or analogue). Current or planned therapy with experimental (i.e., unapproved) insulin. Patients on therapy for type 2 diabetes (e.g. metformin) should stop their therapy in order to be eligible for study participation.
• Use of medications known to influence glucose tolerance
• Daily use of non-steroidal anti-inflammatory agents
• Compromised GI mucosal integrity or motility, not attributable to T1D (i.e., recent diarrhea, gluten sensitive enteropathy, inflammatory bowel disease, irritable bowel syndrome), or current use of medications known to influence GI motility
• Positive result of SARS-Cov2 PCR test at screening or within 3 days before randomization

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of California, San Francisco — San Francisco, California, United States
• Coastal Metabolic Research Centre — Ventura, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale Center for Clinical Investigation — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Barry J Reiner, MD, LLC — Baltimore, Maryland, United States
• University of Minnesota Health — Minneapolis, Minnesota, United States
• University of Missouri-Kansas City School of Medicine — Kansas City, Missouri, United States
• Sanford Children's Specialty Clinic — Sioux Falls, South Dakota, United States
• University Diabetes and Endocrine Consultants — Chattanooga, Tennessee, United States
• Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States
• Research Institute of Dallas — Dallas, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• UZ Brussel — Brussels, Belgium
• UZ Antwerpen — Edegem, Belgium
• UZ Leuven — Leuven, Belgium

Full record on ClinicalTrials.gov

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