Tegoprubart + Islet Cell Transplant for Type 1 Diabetes

Overseen By Minelly Escobedo

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Chicago

Must not be taking: Immunosuppressants, Biologics, JAK inhibitors, others

Disqualifiers: Obesity, Hypertension, Cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with type 1 diabetes who also have chronic kidney disease and frequently experience low blood sugar episodes. The study combines an experimental drug, Tegoprubart, with transplanted human pancreatic islet cells to assess the safety and effectiveness of this combination. Researchers seek participants who have had type 1 diabetes for 5 or more years, use insulin therapy but still struggle with blood sugar management, and have kidney issues. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tegoprubart holds promise in early studies for aiding islet transplantation in individuals with type 1 diabetes. Initial findings suggest it may cause fewer harmful side effects than some other treatments while still protecting the transplanted cells. Importantly, studies have found that Tegoprubart does not harm the kidneys or insulin-producing cells.

Previous studies on human pancreatic islet cells have demonstrated their potential to help manage blood sugar levels in people with type 1 diabetes. Some reports indicate that islet transplantation can improve blood sugar control and reduce the need for insulin, though the long-term survival of the transplanted cells can vary.

Both Tegoprubart and human pancreatic islet cells remain under study and are not yet approved by the FDA for general use. While early results are promising, further research is necessary to fully understand their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for Type 1 Diabetes because it combines tegoprubart with human pancreatic islet cell transplants. Unlike standard treatments like insulin therapy, which only manages blood sugar levels, this approach aims to restore the body's ability to produce insulin naturally. Tegoprubart is an immunomodulatory drug that helps prevent the immune system from attacking the newly transplanted islet cells, potentially leading to a more effective and lasting solution for managing diabetes. This innovative combination holds the promise of reducing or even eliminating the need for daily insulin injections.

What evidence suggests that this investigational regimen could be effective for Type 1 Diabetes?

This trial will evaluate the combination of Tegoprubart and human pancreatic islet cell transplants for type 1 diabetes. Studies have shown that Tegoprubart, when used in islet cell transplants, has helped some patients with long-standing type 1 diabetes stop needing insulin and maintain good blood sugar levels. Early results suggest it might reduce the risk of transplant rejection by making the immune system less likely to attack the new cells. Transplants of human pancreatic islet cells have also successfully improved blood sugar control and reduced episodes of low blood sugar. Long-term results indicate that islet transplants can provide lasting improvements in blood sugar levels. Together, these treatments show promise for better managing type 1 diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with type 1 diabetes that is hard to control (brittle T1D) and moderate chronic kidney disease (stage 2-3a). Participants should not have other major health issues that would make the study unsafe for them.

Inclusion Criteria

I use an insulin pump or daily injections but still have severe low blood sugar episodes.

Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM)

Impaired awareness of hypoglycemia based on one of the following: HypoA-Q Impaired Awareness Subscale ≥12 with 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%; or Clarke Score >4; or recurrent SHE defined by two or more level 3 SHEs in the year prior to screening

Exclusion Criteria

History of substance abuse within past 6 months

Baseline panel reactive antibody (PRA) over 40%

Persistent elevation of AST or ALT >3 times upper limit of normal; total bilirubin >1.5 times upper limit of normal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tegoprubart and everolimus along with islet cell transplantation

1 year

Regular visits for monitoring and medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Annual visits for assessment

What Are the Treatments Tested in This Trial?

Interventions

• Everolimus
• Human Pancreatic Islet Cells
• Tegoprubart

Trial Overview

The study tests a combination of an experimental drug called Tegoprubart, everolimus, anti-thymocyte globulin, etanercept, and transplanted human pancreatic islet cells. All participants receive this treatment to see if it helps manage diabetes safely.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Breakthrough T1D

Collaborator

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4664938/

Pancreas Islet Transplantation for Patients With Type 1 ... - PMC

The evidence on allogeneic pancreatic islet cell transplantation for type 1 diabetes mellitus shows short-term efficacy with some evidence of long-term efficacy ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1600613522088049

Ten-year outcomes of islet transplantation in patients with ...

With a 10-year follow-up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01909245

NCT01909245 | Islet Cell Transplant for Type 1 Diabetes

In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some ...

4.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/7/1068/158190/Advances-in-Cell-Replacement-Therapies-for

Advances in Cell Replacement Therapies for Diabetes

The Miami group reported a 90% 20-year patient survival in 49 patients, with marked reduction in diabetes-related mortality in comparison with ...

5.

thelancet.com

thelancet.com/journals/landia/article/PIIS2213-8587(24)00341-3/abstract

Long-term outcomes of pancreatic islet transplantation ...

This study aimed to evaluate long-term outcomes of islet transplantation alone for type 1 diabetes, focusing on the effects of islet mass and immunosuppressive ...

6.

cell.com

cell.com/cell/fulltext/S0092-8674(24)01022-5

Transplantation of chemically induced pluripotent stem ...

Promising results from this patient suggest that further clinical studies assessing CiPSC-islet transplantation in type 1 diabetes are warranted ...

7.

diatribe.org

diatribe.org/diabetes-research/first-fda-approved-islet-cell-transplant-performed

First FDA-Approved Islet Cell Transplant Performed

It was the first cell therapy to ever be approved by the FDA for people with type 1 diabetes. Lantidra is only available at University of Illinois Chicago ...

8.

southcarolinablues.com

southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/islet-cell-transplantation/

Islet Cell Transplantation

Allogeneic islet transplantation potentially offers an alternative to whole-organ pancreas transplantation in patients with type 1 diabetes.2, In the case of ...