Actively Recruiting
Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody
Led by PolTREG S.A. · Updated on 2026-01-16
150
Participants Needed
8
Research Sites
403 weeks
Total Duration
On this page
Sponsors
P
PolTREG S.A.
Lead Sponsor
I
Invicta Sp. z o.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of the study is to check: * Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes? * Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal/high insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background). In order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study. The participant will be randomly assigned to one of four groups: * Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies, * Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo) * Group III will receive a preparation of antiCD20 antibodies along with a sham treatment (inert substance) * Group IV will receive an agent containing an inert substance and sham treatment. Approximately 150 patients aged 6-16 who are at risk of developing type 1 diabetes will be enrolled in the study, which will last up to 96 months. Each enrolled participant will remain in the study for up to five years.
CONDITIONS
Official Title
Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 16 years
- Body mass index between the 25th and 75th percentile for age and weight of at least 20 kg
- Fasting venous plasma glucose levels between 70 and 100 mg/dl and normal glucose tolerance test (less than 140 mg/dl at 120 minutes)
- No insulin dependence
- C-peptide levels at or above 1.0 ng/ml in fasting and a 100% or greater increase after stimulation
- No previous diagnosis of stage 2 or 3 type 1 diabetes and no history of dysglycemia or diabetes symptoms
- HbA1c level below 5.7%
- Positive autoantibody levels for two or more antibodies at low titers (2-4 times normal), with re-screening allowed if one antibody is high
- Ability of the child's legal representatives (and child if over 13) to provide informed consent
- Ability of legal representatives to manage diabetes by controlling blood glucose at least three times daily and correctly dosing insulin
- Venous access to allow blood sample collection
You will not qualify if you...
- Refusal or lack of signed informed consent
- Diagnosis or suspicion of diabetes other than type 1
- Age under 6 or over 16 years
- IgA deficiency or other immunodeficiency with frequent infections
- C-peptide levels below 1.0 ng/ml fasting or less than 100% increase after stimulation
- Venous blood glucose levels 100 mg/dl or higher fasting
- Glucose levels 200 mg/dl or higher after 1 and 2 hours in oral glucose tolerance test
- HbA1c level 5.7% or higher
- BMI below 25th or above 75th percentile or weight under 20 kg
- History of hypersensitivity to anti-CD20, penicillin, or streptomycin
- Past or active infections with HBV, HCV, HIV, HTLV I/II, tuberculosis, syphilis, EBV, or CMV
- Any fungal, parasitic, viral, or bacterial infection
- History of cancer
- Blood cell counts below normal within 6 weeks prior to inclusion
- History of thrombosis or elevated thrombotic activity
- Chronic medication use for more than 3 months prior to inclusion
- Diagnosed autoimmune diseases other than type 1 diabetes, including Hashimoto's and celiac disease
- Use of anti-diabetic medications including insulin within 4 weeks prior
- History of retinopathy, hypertension, or albuminuria
- Pregnancy or unwillingness to use effective contraception during and 4 months after trial for women of childbearing potential
- Breastfeeding
- Males over 15 intending to father children or donate sperm during or 4 months after trial
- Excessive anxiety about trial procedures
- Any medical condition that might worsen health during the trial
- Substance addiction in legal representatives or children over 15
- History of unknown cause diseases, Creutzfeldt-Jacob disease, dementia, or neurological disease
- History of hormone treatments derived from human pituitary gland
- Treatment with immunosuppressants
- History of certain transplants or neurosurgery
- Risk factors related to travel with possible infectious disease exposure
- Physical signs indicating infectious disease risk
- History of xenogeneic transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Bialystok, Poland, 15-269
Actively Recruiting
2
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-211
Actively Recruiting
3
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Katowice, Poland, 40-752
Not Yet Recruiting
4
Uniwersytet Medyczny W Lodzi
Lodz, Poland, 90-419
Actively Recruiting
5
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, Poland, 20-093
Actively Recruiting
6
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland, 45-401
Actively Recruiting
7
Centrum Medyczne Medyk Sp. z o.o. S.K.
Rzeszów, Poland, 35-326
Actively Recruiting
8
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, Poland, 50-556
Actively Recruiting
Research Team
M
Marta Druch, Clinical Trial Director
CONTACT
G
Grzegorz Orlik, Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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