RecruitingPhase 1/2

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)

United States70 participantsStarted 2024-03-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Men and women 18-65 years of age.
✓. A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age.
✓. Ability to provide informed consent.
✓. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).
✓. Involvement in appropriate diabetes management in accordance with the standard of care, as directed by an endocrinologist or diabetologist with at least 4 (quarterly) clinical evaluations within the 12 months prior to Screening; using CGM\*: using an insulin pump or multiple daily injection (MDI) of insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs- at least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening.
✓. At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening.
✓. HbA1c level 6.5% (48 mmol/mol) to 9.5% (80 mmol/mol), inclusive.
✓. Absence of stimulated C-peptide (\<0.3 ng/mL) in response to a 240-minute mixed- meal tolerance test (MMTT).

Exclusion criteria

What they're measuring

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

Timeframe: Day 75 and Day 365

Trial details

NCT IDNCT06305286

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03

Contact for this trial

Piotr Witkowski, MD PhD

773-702-2447 isletcelltx@bsd.uchicago.edu

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials