City of Hope Now Recruits for Phase 1 Clinical Trial Investigating Immunotherapy (Vaccine) for Type 1 Diabetes

City of Hope Now Recruits for Phase 1 Clinical Trial Investigating Immunotherapy (Vaccine) for Type 1 Diabetes TrialsiteN

The City of Hope now seeks patients for a Phase 1 clinical trial centering on an investigational vaccine that uses a person’s own cells, a beta cell protein and vitamin D3 to potentially treat Type 1 Diabetes. Part of the Wanek Family Project for Type 1 Diabetes at City of Hope, the trial is but one of a number of initiatives part of a quest to find a cure for diabetes. A first-of-its-kind trial for Type 1 Diabetes, the approach now unfolds in the United States but was tested in Europe and evidenced positive early results. Known as the PIpepToIDC vaccine, the “inverse” vaccine, which was previously evaluated for safety and feasibility in a clinical trial in the Netherlands, now will be tested for the first time in America.

TrialSite breaks this important update down for the TrialSite Network.

What is the PipepToIDC vaccine study?

The Phase 1 clinical trial (NCT04590872) investigates the side-effects PipepToIDC vaccine in treating patients with Type 1 diabetes who use insulin and don’t have any other diabetes-related health complications.

As Type 1 diabetes is an autoimmune disease, this means that the patient’s immune system, which usually protects against foreign invaders such as bacteria or viruses, attacks the body’s insulin-producing beta cells in the pancreas: this represents the autoimmune response.

This process leads to the destruction of the beta cells by the patient’s own immune system. To remain alive, diabetes Type 1 patients must use insulin. 

What is the trial eligibility?

This clinical trial is open to adults with Type 1 diabetes between the ages of 18 and 45 who were diagnosed with Type 1 diabetes in the last one to four years, where there are many more beta cells to be preserved and protected. Other eligibility and exclusion criteria for the trial can be found here.

Has COVID-19 impacted this study?

Yes. The clinical trial is open and recruiting patients, but due to pandemic conditions, patients will not be able to receive the vaccine until the pandemic is more under control. In the meantime, patients will be screened for trial eligibility.

What is the PipepToIDC treatment?

This cell therapy-based vaccine is a type of immunotherapy (a treatment that uses a person’s own immune system) that works like an allergy shot. The vaccine is made using one’s own immune cells (dendritic cells) and a beta-cell protein. In this study, the City of Hope investigators and study team will develop the investigational vaccine with the patient’s own dendritic cells, a type of immune cell. In the City of Hope laboratory, these cells will be cultured and loaded with vitamin D3 and a fragment of pro-insulin to help train the immune system to reduce inflammation. 

Patients will receive the modified immune cells via two injections, one month apart.

The hope here is that the vaccine may actually condition or teach the immune system to stop attacking the beta cells, which may help the beta cells’ recovery and thereafter, generate enough insulin to control blood sugar levels. It is hoped that this vaccine could help reduce future Type 1 diabetes-related complications.

Is City of Hope using new type of delivery method?

Yes. For the trial, City of Hope will also use a new type of conduit to deliver a treatment called microneedles, which are grouped together and applied like a transdermal patch, injecting the immune cells under the skin of patients rather than straight into the blood or muscle. This novel approach was used in the Netherlands trial.

What occurred during the Netherlands trial?

In this early-stage study, 9 participants were treated with the vaccine. They were monitored for six months thereafter. The investigators observed no signs of systemic immune suppression or major adverse event. Furthermore, beta-cell function and overall diabetic control remained stable, and all patients maintained healthy blood sugar levels after treatment.

Interestingly, these participating patients were diagnosed with Type 1 diabetes for as long as 10 years. Even though these patients no longer produced insulin or much less than patients with a more recent diagnosis, the vaccine still evidenced some positive effects.

Is there any current approved immunotherapy for Type 1 diabetes?

No

Principal investigator Point of View

Bart O. Roep, PhD, City of Hope’s Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and director of the Wanek Family Project commented, “There is currently no approved immunotherapy for Type 1 diabetes patients, and the City of Hope aims to change that.”

Roep helped lead the clinical trial for the diabetes vaccine in the Netherlands and reported “Our trial aims to engage a person’s immune system, rather than suppress it, and to try to stop it from attacking the insulin-producing cells. The vaccine could also have the positive effect of preventing diabetic complications like blindness and neuropathy.”

Finally, the City of Hope lead declared “It is a very exciting time for Type 1 diabetes as we move from treating the symptoms to actually trying to stop the disease.”

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, check their social media (FacebookTwitterYouTube or Instagram).

Lead Research/Investigator

Bart O. Roep, PhD, City of Hope’s Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and director of the Wanek Family Project