Tolerogenic Dendritic Cell Vaccine for Type 1 Diabetes

Overseen By Study Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must be taking: Insulin

Must not be taking: Corticosteroids, Immunosuppressives, Monoclonals, others

Disqualifiers: Organ transplant, Malignancy, Infections, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine designed to assist people with type 1 diabetes. The vaccine aims to retrain the immune system to stop attacking insulin-producing cells in the pancreas, potentially allowing these cells to recover and produce insulin naturally. This could improve blood sugar management and reduce future complications associated with type 1 diabetes. Suitable participants have had type 1 diabetes for 1 to 4 years, use insulin, and have no other diabetes-related health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, such as systemic corticosteroids, systemic immunosuppressive therapy, and insulin sensitizers, before joining. Over-the-counter anti-inflammatory drugs like ibuprofen are generally allowed, but chronic use during study visits is not permitted.

Is there any evidence suggesting that the PIpepTolDC vaccine is likely to be safe for humans?

Research has shown that the PIpepTolDC vaccine, a treatment for type 1 diabetes, has undergone safety testing in early studies. These studies found that using dendritic cells, a type of immune cell, is safe for people with type 1 diabetes. The vaccine works by using the patient’s own immune cells to help stop the body from attacking insulin-producing cells.

In these studies, most patients tolerated the vaccine well, experiencing no serious side effects. Some individuals experienced mild reactions, such as redness or swelling at the injection site. Overall, early research suggests that the PIpepTolDC vaccine is safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Unlike the standard of care for Type 1 Diabetes, which typically involves insulin therapy and blood sugar monitoring, PIpepTolDC acts on the immune system itself. This treatment uses a unique approach by employing tolerogenic dendritic cells combined with a proinsulin peptide to potentially retrain the immune system to stop attacking insulin-producing cells. Researchers are excited because this could address the root cause of the disease rather than just managing its symptoms, offering hope for a more durable solution.

What evidence suggests that the PIpepTolDC vaccine might be an effective treatment for type 1 diabetes?

Research has shown that the PIpepTolDC vaccine, which participants in this trial will receive, might help treat type 1 diabetes. This vaccine uses a person's own immune cells to teach the immune system to stop attacking the insulin-producing cells in the pancreas. This process could help these cells recover and produce enough insulin to manage blood sugar levels. Early results suggest that the vaccine can gradually reduce the immune system's harmful response. This method resembles how allergy shots work, aiming to change the immune system's reaction. Although more research is needed, the initial findings are promising and offer hope for reducing diabetes complications in the future. ^{1 3 4 6 7}

Who Is on the Research Team?

Behrouz Salehian-Dardashti, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people with type 1 diabetes who use insulin, have stable blood sugar control, and no other diabetes complications. They must be willing to undergo a procedure to collect immune cells and not have certain genetic traits or previous severe allergic reactions.

Inclusion Criteria

My organs are functioning well.

I do not have diabetes-related complications like kidney, eye, or nerve damage.

I am eligible for a procedure to collect my own cells.

Exclusion Criteria

I have a history of HIV, hepatitis B, hepatitis C, HTLV, or syphilis.

I am not on any prescription anti-inflammatory drugs, but I may use OTC like ibuprofen or Tylenol.

I haven't taken diabetes medication that stimulates insulin production in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Participants undergo leukapheresis to collect CD14+ monocytes for vaccine preparation

1 day

1 visit (in-person)

Treatment

Participants receive a prime dose of PIpepTolDC intradermally on Day 0, followed by a boost dose on Day 28

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PIpepTolDC

Trial Overview The PIpepTolDC vaccine, an immunotherapy made from the patient's own immune cells mixed with a beta cell protein, is being tested. It aims to retrain the immune system to stop attacking pancreatic beta cells in type 1 diabetics.

How Is the Trial Designed?

Group I: Autologous Tolerogenic Dendritic Cell with Proinsulin Peptide (PIpepTolDC) Experimental Treatment 1 Intervention

After completion of leukapheresis, patients receive a prime dose of PIpepTolDC intradermally (ID) on Day 0, followed by a boost dose of PIpepTolDC ID on Day 28.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04590872

Study Details | NCT04590872 | An Immunotherapy Vaccine ... This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36505460/

Tolerogenic dendritic cells pulsed with islet antigen induce ... Tolerogenic dendritic cells pulsed with islet antigen induce long-term reduction in T-cell autoreactivity in type 1 diabetes patients · Abstract.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10303908/

Tolerogenic dendritic cells in type 1 diabetes - PubMed Central Tolerogenic dendritic cells (tDC) arrest the progression of autoimmune-driven dysglycemia into clinical, insulin-requiring type 1 diabetes (T1D)

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-06975

A Vaccine (PIpepTolDC) for the Treatment of Patients with ... This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other ...

5. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-type-1-9-2021-137ee

Tolerogenic Dendritic Cell Vaccine for Type 1 Diabetes This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3161299/

Phase I (Safety) Study of Autologous Tolerogenic Dendritic ... We investigated the safety of autologous dendritic cells, stabilized into an immunosuppressive state, in established adult type 1 diabetic patients.

7. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(20)30104-2/fulltext

Safety and feasibility of intradermal injection with ... Here, we present the safety and feasibility data of a first-in-man prospective, open label, placebo-controlled, dose escalation, phase 1 trial ...