Actively Recruiting
A Multicenter, Randomized, Blinded, Placebo Controlled Phase II Study of Cell Therapy Using Expanded Regulatory T Cells and Anti-CD20 Antibody in Children With Early Type 1 Diabetes
Led by PolTREG S.A. · Updated on 2026-01-16
150
Participants Needed
8
Research Sites
N/A
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
Researchers are evaluating whether therapies using regulatory T cells (Tregs lymphocytes) and/or an anti-CD20 antibody (rituximab) can safely treat or delay type 1 diabetes in children with pre-diabetes. This study focuses on high-risk children aged 6 to 16 years who still produce normal or high insulin levels and have confirmed autoimmune markers. It is a randomized, placebo-controlled, blinded phase 2 trial aiming to assess both safety and effectiveness of these treatments. Participants will be randomly assigned to one of four groups: one group will receive both Tregs and anti-CD20 antibody; the second group will receive Tregs with a placebo; the third group will get anti-CD20 antibody with a sham treatment; and the fourth group will receive placebo and sham treatments. Treatments involve infusions on day 0 and again around day 90, with additional dosing of antibodies or placebos as appropriate. The intervention phase lasts about 3 months, followed by long-term monitoring. During the study, participants will undergo screening tests to confirm eligibility, including blood tests for glucose levels, insulin production, and autoantibodies. After treatment, participants will be monitored for up to five years to observe the development of type 1 diabetes. The study measures include the time to onset of dysglycemia, adverse events, insulin use, C-peptide levels, and autoimmune markers. Safety assessments focus on infections and immune system effects throughout the trial period lasting up to 96 months.
CONDITIONS
Brief 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...
- Ages 6 to 16 years
- Body mass index between the 25th and 75th percentile with a minimum weight of 20 kg
- Fasting venous plasma glucose below 100 mg/dL and normal glucose tolerance at 120 minutes
- Not dependent on insulin treatment
- C-peptide levels at or above 1.0 ng/ml with at least 100% increase after stimulation
- No diagnosis of stage 2 or 3 type 1 diabetes; no history of dysglycemia or diabetes symptoms
- HbA1c level less than 5.7%
- Presence of low titers of two or more diabetes-related autoantibodies
- Ability of legal representatives to provide informed consent; child consent if over 13
- Legal representatives capable of managing diabetes care including blood glucose monitoring and insulin dosing
- Venous access suitable for blood sampling
You will not qualify if you...
- Refusal to participate or lack of signed informed consent
- Diagnosis or suspicion of diabetes other than type 1
- Age below 6 or above 16 years
- IgA deficiency or other immunodeficiency with frequent infections
- C-peptide levels below 1.0 ng/ml or less than 100% increase after stimulation
- Fasting venous glucose levels of 100 mg/dL or higher
- Glucose levels of 200 mg/dL or higher after 1 or 2 hours in oral glucose tolerance test
- HbA1c level 5.7% or higher
- Body mass index outside 25th to 75th percentile or weight under 20 kg
- History of allergic reactions to anti-CD20 or components, penicillin, or streptomycin
- Past or active infections including hepatitis, HIV, tuberculosis, syphilis, EBV, CMV, or others
- History of cancer
- Blood disorders such as anemia, lymphopenia, neutropenia, or thrombocytopenia
- History of thrombosis or elevated clotting activity
- Chronic diseases requiring medication for over 3 months
- Autoimmune diseases other than type 1 diabetes
- Recent use of anti-diabetic medications including insulin
- History of retinopathy, hypertension, or albuminuria
- Pregnancy, breastfeeding, or unwillingness to use contraception if applicable
- Intent to father children or donate sperm during or soon after the trial for males over 15
- Severe anxiety about the trial procedures
- Medical conditions that could worsen health during the trial
- Alcohol or substance addiction
- History of unknown diseases, Creutzfeldt-Jacob disease, degenerative neurological diseases
- Prior hormone treatments from human pituitary gland
- Use of immunosuppressants
- History of certain transplants or neurosurgery
- Risk factors from travel to infectious disease regions
- Physical signs suggesting infection risk
- History of xenogeneic transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 36 months
Participants are screened for eligibility to participate in the trial.
Participants will undergo screening assessments to confirm stage 1 type 1 diabetes and eligibility criteria.
Duration - Approximately 3 months
Participants receive infusions of regulatory T cell preparations and/or anti-CD20 antibody or placebo according to their assigned group.
2 infusions of Treg or sham preparation at day 0 and around day 90, plus 4 doses of anti-CD20 antibody or placebo during this period
Duration - Up to 57 months after first treatment dose
Participants are monitored for the onset of type 1 diabetes mellitus and safety outcomes following treatment.
Annual visits for up to 5 years to assess diabetes progression and adverse events
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
G
Grzegorz Orlik, Medical Director
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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