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NCT06305286 · ClinicalTrials.gov registry record · Phase 1

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 Phase 1 study of Type 1 Diabetes Mellitus, sponsored by University of Chicago.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT06305286 is a Phase 1 study of Type 1 Diabetes Mellitus that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 70 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06305286, a Phase 1 study of Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by University of Chicago.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Tegoprubart (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. Tegoprubart (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. Tegoprubart (AT-1501) is an experimental agent that is anticipated to prevent rejection without harming the islet cells.

Conditions Studied

Type 1 Diabetes Mellitus

Interventions

  • DRUG Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy

Study Locations (1)

Illinois

  • University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2024-03-04
Est. Completion 2029-03
Phase Phase 1

Sponsor

University of Chicago

796 total trials

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What the Registry Record Tells You About NCT06305286

The ClinicalTrials.gov registry entry for NCT06305286 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (50% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy is the first listed.

NCT06305286 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT06305286 about?

NCT06305286 is a clinical study titled "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)". Tegoprubart (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 d...

What is the current status of trial NCT06305286?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2024-03-04. Estimated completion is 2029-03.

What conditions does trial NCT06305286 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.

What interventions are being tested in trial NCT06305286?

The interventions under investigation include: Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy (DRUG).

Who is sponsoring clinical trial NCT06305286?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06305286 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.