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New treatment option for Diabete Type 1
Official title Breakthrough - T1DM and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT07592000
What this study is testing
What is Tegoprubart?
Tegoprubart is an investigational medicine, being studied as a potential treatment for diabete type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single arm- subject treated with Tegoprubart and everolimus. The purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components: An investigational drug called Tegoprubart and Human pancreatic islet cells Both Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants are eligible for consideration for the study only if all of the following criteria apply at the time of screening Inclusion:
- people 18-70 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).
You likely can't join if
- Body mass index (BMI) \>30 kg/m2.
- Weight ≤40 kg.
- Insulin requirement \>60units/day or \<15 units/day.
- Untreated and uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg.
- Chronic kidney disease stage 3b or above.
See the full eligibility criteria
Who can join
- Participants are eligible for consideration for the study only if all of the following criteria apply at the time of screening Inclusion:
- people 18-70 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, using an insulin pump or multiple daily injection (MDI) insulin therapy and, unable to achieve acceptable metabolic control because...
- HbA1c level 6.5% to 9.5% inclusive.
- Absence of stimulated C-peptide (\<0.3 ng/mL) in response to a mixed- meal tolerance test (MMTT).
- Chronic kidney disease stage 1, 2 or 3a
- Impaired awareness of hypoglycemia based on:
- IAH (HypoA-Q Impaired Awareness Subscale ≥12) and at least one level 3 SHE during the last year or
- IAH and time-below-range (\<70 mg/dl) ≥4% with level 2 hypoglycemia (\<54 mg/dl) ≥1% (in Diabetes Care, Jan 2025, Patrick Choudhary) or
- Clarke Score \>4 or
- Recurrent SHE defined by two or more level 3 SHEs in the year prior to screening
- If female, must be surgically sterile or postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that...
What rules you out
- Body mass index (BMI) \>30 kg/m2.
- Weight ≤40 kg.
- Insulin requirement \>60units/day or \<15 units/day.
- Untreated and uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg.
- Chronic kidney disease stage 3b or above.
- Diagnosis of macroalbuminuria (ACR\>300 mg/g creatinine).
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male...
- History of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation:
- Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable...
- Patients on aspirin are allowed.
- Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.
- Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of...
- Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.
- Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.
- Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.
- Baseline PRA over 40%
- Previous organ transplant (except failed pancreas or islet transplant)
- Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin \>1.5 ULN.
- Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer.
- History of substance abuse within the past 6 months.
- Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d)...
- Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol \>130 mg/dL and/ or triglycerides \>200 mg/dL.
- Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL). Participants with lymphopenia are allowed if the...
- Administration of live attenuated vaccine(s) within 2 months of Screening.
- Any previous treatment with Tegoprubart or any other anti-CD40L therapy
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.