AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 1NCT04590872

An Immunotherapy Vaccine (PIpepTolDC) for the Treatment of Patients With Type 1 Diabetes

A Phase 1 study testing Tolerogenic Dendritic Cell Vaccine in people with Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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 diabetes-related health complications. Type 1 diabetes is an autoimmune disease. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Tolerogenic Dendritic Cell Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
16 Jun 2022to 15 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Willingness to undergo leukapheresis
  • Willingness to be followed for about 2 years post-prime dose
  • For participants who have a personal continuous glucose monitoring device (CGMD): Willingness to wear a second CGMD during mandated study CGMD visits
  • Diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria
  • Historical presence of at least one type-1 diabetes associated autoantibody
  • GAD specific autoantibodies (glutamic acid decarboxylase autoantibodies [GADA])
Show all 22Show fewer
  • Islet cell cytoplasmic autoantibodies (ICA)
  • Islet-antigen 2 specific autoantibody (IA-2A)
  • Zinc transporter 8 specific autoantibody (ZNT8A); and/or
  • Insulin autoantibody (IAA) (must have been obtained within 7 days of initiating exogenous insulin replacement therapy)
  • Time from diagnosis to screening mixed meal tolerance test (MMTT) must be >= 1 year but =< 4 years
  • Stable glycemic control per participant's physician
  • HbA1c =< 7.5% (=< 58 mmol/mol)
  • Non-fasting C-peptide > 0.017 nmol/L
  • Stimulated peak C-peptide levels > 0.2 nmol/L from a 2-hour screening MMTT
  • Positive for *04:01 allele, *04:02 allele and/or *04:04 allele at the human leukocyte antigen (HLA)-DRB1 gene locus
  • Does not possess the protective HLA-DRB1*15:01-DQA1*01:02-DQB1*06:02 haplotype
  • Adequate self-assessment of blood glucose values and recording of glucose values, and administered insulin doses as deemed sufficient by the participant's physician
  • No diagnosis of type 1 diabetes related microvascular/macrovascular complications (e.g. nephropathy, retinopathy and neuropathy)
  • Deemed acceptable for autologous cell collection (i.e. leukapheresis)
  • Only for those who are naive to CGMD use: Deemed able to correctly use a CGM device following training session with a certified diabetes educator and manufacturer representative
  • Must meet organ function criteria

Who cannot join

  • Other investigational agents, biologics
  • Anti-inflammatory therapy
  • Exception: Over-the-counter (OTC) anti-inflammatory agents (e.g. ibuprofen, Tylenol) are generally allowed. However, those requiring chronic OTC anti-inflammatory agents and unable to stop during mandated CGMD study visits will be excluded
  • Systemic corticosteroids within 28 days prior to leukapheresis
  • Systemic immunosuppressive therapy (e.g. cyclosporine-A, cyclophosphamide)
  • Monoclonal antibody therapy
Show all 23Show fewer
  • Allergen immunotherapy within 28 days prior to leukapheresis
  • Vaccine(s) within 28 days prior to leukapheresis
  • Prior allogeneic organ transplant
  • Beta-cell stimulants (e.g. sulfonylureas such as glimepiride), glucagon-like peptide-1 agonists, dipeptidyl peptidase-IV inhibitors (exception: Those with acute exposure to these agents during T1D misdiagnosis may be permitted per PI discretion)
  • Insulin sensitizers (e.g. metformin, thiazolidinediones) within 2 months of leukapheresis
  • History of insulin sensitizer use (e.g. metformin, thiazolidinediones) ≥ 2 months
  • Other autoimmune/inflammatory disorders (exceptions: (i) Type 1 diabetes. (ii) Asymptomatic patients with incidental autoantibody titres may be permitted per PI discretion)
  • Other autoimmune/inflammatory disorders (exception type 1 diabetes)
  • Active infection requiring antibiotics and/or anti-virals
  • Known history of HIV, HBV, HCV, HTLV, syphilis
  • History of positive purified protein derivative (PPD) skin test
  • History of atopy requiring systemic treatment and/or history of severe allergic reactions
  • History or current malignancy
  • Unstable cardiac disease
  • History of vascular disease (e.g. deep vein thrombosis, stroke)
  • Clinically significant uncontrolled illness
  • Females only: pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Safety and Feasibility of Autologous Tolerogenic Dendritic Cells Loaded With Proinsulin Peptide (C19-A3) in Patients With 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 diabetes-related health complications. Type 1 diabetes is an autoimmune disease. This means that the immune system, which usually protects against foreign invaders like bacteria and viruses, attacks the body's insulin-producing betacells in the pancreas (autoimmune response). Overtime, the beta cells are destroyed by the immune system. To stay alive, people with type 1 diabetes must use insulin. PIpepTolDC 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. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.

Being tested
Tolerogenic Dendritic Cell Vaccine
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tolerogenic Dendritic Cell VaccineBiological

    PIpepTolDCs

Study groups in NCT04590872
Study groupRoleWhat they receive
Autologous Tolerogenic Dendritic Cell with Proinsulin Peptide (PIpepTolDC)ExperimentalAfter 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.
Receives: Biological: Tolerogenic Dendritic Cell Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Toxicity and adverse events (except hypoglycemia and diabetic ketoacidosis [DKA]) will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Hypoglycemia events and DKA will be defined per American Diabetes Association (ADA) grading systems.Observed toxicities will be summarized by type, severity (by CTCAE v 5.0 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution.

    Measured: Up to 2 years

  2. Apheresis duration

    Measured in hours.

    Measured: up to 2 years

  3. Number of CD14+ monocytes

    Number of CD14+ monocytes collected during apheresis

    Measured: up to 2 years

  4. TolDC recovery after culture

    Number of TolDC generated from CD14+ monocytes

    Measured: up to 2 years

  5. Number of successful manufactured products

    Number of manufactured products that meet the required cell dose/day, sterility (e.g. endotoxin and gram staining), and viability compared to the total number of products manufactured.

    Measured: Up to 2 years

Secondary outcomes (9)

  1. Change in stimulated C-peptide area under the curve

    Assessed via 2-hr mixed meal tolerance test (MMTT). C-peptide preservation is defined as the maintenance of baseline C-peptide levels.

    Measured: Baseline up to 2 years of follow up

  2. Change in interferon (IFN)-gamma and IL-10 producing CD4+ T cells

    Will be assessed in response to pro-insulin peptide C19-A3, and assessed via cytokine enzyme-linked immunosorbent spot assay.

    Measured: Baseline up to 2 years of follow up

  3. Change in T cell responsiveness

    Will assess for changes in T cell responsiveness to pro-insulin peptide C19-A3 compared to other antigens. Assessed via Lymphocyte Simulation Test.

    Measured: Baseline up to 2 years of follow up

  4. Change in the number of CD8+ autoreactive T cells

    Assessed via quantum dot (Q-DOT) nanotechnology assay.

    Measured: Baseline up to 2 years of follow up

  5. Change in immune phenotype

    Will analyze for changes in immune cell populations via flow cytometry

    Measured: Baseline up to 2 years of follow up

  6. Change in islet autoantibodies

    Will analyze for changes in IAA, GAA, IA-2A, ZnT8A via enzyme-linked immunosorbent assay.

    Measured: Baseline up to 2 years of follow up

  7. Change in glycosylated hemoglobin A1c (HbA1c) levels

    HbA1c levels will be assessed via blood test

    Measured: Baseline up to 2 years of follow up

  8. Change in exogenous insulin use (units/kg)

    Insulin usage will be recorded daily from the insulin pump and/or participant insulin use logs. The mean daily insulin usage over the 10 consecutive days (IU units/kg body weight/day) preceding the clinic visit will be calculated for each participant.

    Measured: Baseline up to 2 years of follow up

  9. Change in blood glucose levels

    Will include clinically important/severe hypoglycemia, hyperglycemia and DKA events as assessed by ADA grading systems. Levels of glucose will be assessed from bloods samples taken during the MMTT and from insulin pump/participant insulin logs

    Measured: Baseline up to 2 years of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start16 Jun 2022
  3. Primary completion3 Jun 2024
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04590872
Sponsor's protocol ID
18279
Status last verified
Apr 2026
First submitted
6 Oct 2020
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tolerogenic Dendritic Cell Vaccine in people with Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04590872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in