Actively Recruiting
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)
Led by University of Chicago · Updated on 2026-03-06
70
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
J
Juvenile Diabetes Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 to 65 years of age
- Diagnosis of Type 1 Diabetes for at least 5 years with disease onset before age 40
- Ability to provide informed consent
- Willingness and ability to comply with study procedures including continuous glucose monitoring
- Managed diabetes with at least 4 clinical evaluations in the past year and use of insulin pump or multiple daily injections
- At least 3 unexplained severe hypoglycemic episodes in the past 12 months
- HbA1c level between 6.5% and 9.5%, inclusive
- Absence of stimulated C-peptide (<0.3 ng/mL) after a 240-minute mixed-meal tolerance test
- Impaired awareness of hypoglycemia with a Clarke Score of 4 or more
- If female, surgically sterile or postmenopausal for 2 years, or negative pregnancy test and agreement to use contraception
- Negative COVID-19 PCR test at time of Thymoglobulin infusion
You will not qualify if you...
- Previous solid organ or islet transplant
- Body mass index over 30 kg/m2
- Weight 50 kg or less
- Insulin requirement over 1.0 unit/kg/day or less than 15 units/day
- Uncontrolled proliferative diabetic retinopathy
- Blood pressure over 140/90 mmHg
- Estimated glomerular filtration rate under 60 mL/min/1.73 m2
- Diagnosis of macroalbuminuria (>300 mg/g creatinine)
- Positive pregnancy test, breastfeeding, or unwillingness to use contraception for women; intent to procreate or unwillingness to use contraception for men
- History of malignancy except fully resected skin cancers
- History of thromboembolic events or hypercoagulable state requiring long-term anticoagulation
- Known heparin allergy
- Chronic systemic steroid use except physiologic replacement
- Active infections including tuberculosis, HIV, hepatitis B or C
- Recent invasive fungal infections within one year
- Negative Epstein-Barr Virus IgG screen
- Recent treatment with immunosuppressive or biologic agents within 5 years
- Elevated liver enzymes greater than 3 times normal or bilirubin over 1.5 times normal
- Prior experimental cell or gene therapy or recent investigational agent exposure
- Substance abuse within past 6 months
- Allergy to Boost drink used in testing
- Severe cardiovascular disease such as recent stroke or heart attack, ischemia, or low ejection fraction
- Significant gastrointestinal disease affecting medication absorption
- Uncontrolled hyperlipidemia despite treatment
- Conditions affecting HbA1c accuracy or requiring frequent blood transfusions
- Any other medical condition or planned procedure compromising safety or study integrity
- Low baseline blood counts unless cleared by hematologist
- Coagulopathy or long-term anticoagulant use except low-dose aspirin
- History of factor V deficiency
- Live attenuated vaccine within 2 months
- Prior treatment with Tegoprubart or anti-CD40L therapy
- Panel-reactive antibody over 20%
- Positive COVID-19 PCR at time of Thymoglobulin infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
P
Piotr Witkowski, MD PhD
CONTACT
H
Hannah Gilkey, BSN RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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