Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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
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
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
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Loading...
Central trial contact
Study Coordinator
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal