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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)

Study acronym: Tegoprubart
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 1 → 6 primary endpoints
See other at-risk trials from University of Chicago

Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints shortened, about 8 words
    • Study description expanded, about 2 words
  2. Enrollment closed, study ongoing
    • Site details revised
    v6
  3. Interventions: AT-1501 (Drug) to Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy (Drug)v5 Show 4 more changesShow less
    • Eligibility criteria revised
    • Site contact updated
    • Collaborators: 2 to 4
    • Study description expanded, about 3 words
  4. Enrollment target: 9 to 70v4
  5. Enrollment target: 3 to 9v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Feb 2029 to Mar 2029
    • Start date changed from estimate of Mar 2024 to Mar 4, 2024
    • Study title expanded, about 4 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Chicago
307 trials monitored
See 12 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT06305286
Lead Sponsor University of Chicago
Collaborators: Juvenile Diabetes Research Foundation, Cure Alliance, Breakthrough T1D, Eledon Pharmaceuticals
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 1
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov