Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation

Trial details

Who runs it

Anelixis Therapeutics, LLC

Trial code

NCT04711226

Record updated

10 August 2022

Original description

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.Read full original descriptionShow less

An Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Adults With Type 1 Diabetes Undergoing Islet Cell Transplant

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.

Inclusion: Men and women 18-65 years of age; A diagnosis of T1D ≥5 years with onset of disease at <40 years of age; Involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia; At least 2 unexplained SHEs not secondary to a missed meal or dosing error, etc., in the 12 months prior to Screening; Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive; Absence of stimulated C peptide (< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption; Reduced awareness of hypoglycemia as defined by a Clarke Score [Clarke 1995] of 4 or more at the time of Screening, during the Screening period and within the last 6 months prior to the transplant.

Exclusion: Any previous transplant; HbA1c level less than 7% (53 mmol/mol).

ClinicalTrials.gov NCT04711226