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NCT06305286

Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)

A Pilot Study Assessing the Safety of Using a Monoclonal Antibody Against Cluster of Differentiation 40 (CD40) Ligand to Achieve a Calcineurin Inhibitor-free Immunosuppression Regimen in Patients With Type 1 Diabetes Mellitus (T1D) and Problematic Hypoglycemia Undergoing Islet Cell Transplantation
University of Chicago·Phase 1/2·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Diabetes Mellitus
Drug/Device/Intervention
AT-1501
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Chicago
Location
Chicago, United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
Mar 04, 2024
End date
Mar 01, 2029
Enrollment
3 participants
Primary outcome

Number of Participants who are insulin-independent post- first and final transplant

Summary

AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced
 naturally by the subject's immune system to attack and fight foreign substances that cause
 illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute
 antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the
 immune system's attack process; they can also tone down the immune system. AT-1501 is thought
 to work by dampening down the immune system so that it will be less likely to attack the
 transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin
 inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet
 cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without
 harming the islet cells.

ICD-10 classifications
Diabetes mellitusUnspecified diabetes mellitusOther specified diabetes mellitusUnspecified diabetes mellitus without complicationsUnspecified diabetes mellitus with unspecified complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06305286
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06305286 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by University of Chicago and is currently Recruiting. The study focuses on Diabetes Mellitus. Target enrollment is 3 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.