BridgeMD
Tests treatment safety and results for Type 1 Diabetes Mellitus
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)
ClinicalTrials.gov ID: NCT06305286
What this study is testing
What is Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy?
Islet transplantation with Tegoprubart (AT-1501) immunosupression-based therapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for type 1 diabetes mellitus.
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
- 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.
- 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 65
You may be able to join if
- 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...
You likely can't join if
- Any previous solid organ or islet allotransplant.
- Body mass index (BMI) \>30 kg/m2.
- Weight ≤50 kg.
- Insulin requirement \>1.0 unit/kg/day or \<15 units/day.
- Uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg.
See the full eligibility criteria
Who can join
- 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...
- 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).
- 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.
- 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...
- Patients with Coronavirus Disease 2019 (COVID-19) Polymerase chain reaction (PCR) negative test result at the time of Thymoglobulin infusion.
What rules you out
- Any previous solid organ or islet allotransplant.
- Body mass index (BMI) \>30 kg/m2.
- Weight ≤50 kg.
- Insulin requirement \>1.0 unit/kg/day or \<15 units/day.
- Uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg.
- Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \<60 mL/min/1.73 m2.
- Diagnosis of macroalbuminuria (\>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. a. Participants with a history of clotted venous access not requiring long- term anticoagulation may...
- Known heparin allergy.
- 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, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor agonists, azathioprine, Mercaptopurine...
- 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.
- Allergy to the Boost drink necessary for MMTT
- 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)...
- History of significant gastrointestinal disease such as symptomatic cholecystolithiasis; acute or chronic pancreatitis; symptomatic peptic ulcer disease; severe unremitting diarrhea, vomiting or other disorders...
- Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol \>130 mg/dL and/ or triglycerides \>200 mg/dL.
- History of any conditions that can interfere in the assessment of HbA1c due to increased red blood cell turnover or requirement for regular blood transfusions such as sickle cell disease (HbSS, hematopoietic blood stem...
- History of any other acute or chronic medical condition or pre-planned medical/surgical procedure that, in the opinion of the Principal Investigator, would compromise the safety of participants or the integrity of study...
- 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...
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after islet cell transplantation (low-dose aspirin treatment is allowed) or participants with an international normalized...
- History of factor V deficiency.
- Administration of live attenuated vaccine(s) within 2 months of Screening.
- Any previous treatment with Tegoprubart (AT-1501) or any other anti-CD40L therapy
- Baseline Panel-reactive Antibody (PRA) over 20%
- Patients with COVID-19 positive PCR tests at the time of Thymoglulin infusion.
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 65 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.