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) (NCT06305286)

🧪 Interventions in This Study

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

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Men and women 18-65 years of age.
2. A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age.
3. Ability to provide informed consent.
4. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).
5. 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. \*CGM will be provide to subjects who otherwise qualify for study participation but have not used CGM previously.
6. At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening.
7. HbA1c level 6.5% (48 mmol/mol) to 9.5% (80 mmol/mol), inclusive.
8. Absence of stimulated C-peptide (\<0.3 ng/mL) in response to a 240-minute mixed- meal tolerance test (MMTT).
9. Impaired awareness of hypoglycemia (IAH) as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period, and within the last 6 months prior to the transplant.
10. If female, must be surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use 2 forms of highly effective methods of contraception from Screening, throughout the study, and while receiving immunosuppressive therapy for the functioning graft after the conclusion of the study. Contraception use must continue for 90 days after the last administration of the study drug (see Appendix 5). Male participants must refrain from donating sperm for the duration of the study and agree to not donate sperm for 90 days after last administration of the study drug.
11. Patients with Coronavirus Disease 2019 (COVID-19) Polymerase chain reaction (PCR) negative test result at the time of Thymoglobulin infusion.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Chicago — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Type 1 Diabetes Mellitus

• Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss — Miami, Florida
• Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes — Nashville, Tennessee
• Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring. — Minneapolis, Minnesota
• Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes — Orange, California
• A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation — Chicago, Illinois

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.