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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) - Trial NCT06305286

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.

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NCT06305286
Phase 1/2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06305286
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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

Study Focus

Diabetes Mellitus

AT-1501

Interventional

drug

Sponsor & Location

University of Chicago

Chicago, United States of America

Timeline & Enrollment

Phase 1/2

Mar 04, 2024

Mar 01, 2029

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 mellitus
Unspecified diabetes mellitus
Other specified diabetes mellitus
Unspecified diabetes mellitus without complications
Unspecified diabetes mellitus with unspecified complications

Data Source

ClinicalTrials.gov

NCT06305286

Non-Device Trial