Could a custom vaccine retrain the immune system in type 1 diabetes?
NCT ID NCT04590872
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of immunotherapy for type 1 diabetes. The treatment uses a vaccine made from the patient's own immune cells and a piece of insulin-producing cell protein. The goal is to teach the immune system to stop attacking the pancreas, potentially preserving some insulin production. Six adults with type 1 diabetes who use insulin and have no other diabetes complications are participating.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A vaccine made from the patient's own immune cells (dendritic cells) combined with a piece of insulin-producing cell protein (proinsulin peptide C19-A3)
- What this could lead to
- If it works, this could point toward a way to preserve the body's ability to make some insulin, potentially reducing the need for injected insulin and preventing long-term complications.
- What could go wrong
- This is a very early, small pilot study with only 6 people, so results may not apply broadly. The vaccine may not work, and there could be side effects like allergic reactions or immune system issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 \[GADA\]) * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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Other studies related to the condition(s) this trial covers.
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