Home › Trials › NCT06688331

Treatment for pre-diabetes in children using Treg cells and rituximab

A Multicenter, Randomized, Blinded, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Cell Therapy Based With Artificially Expanded CD4+CD25+CD127- Regulatory Lymphocytes and Anti-CD20 Antibody in Pediatric Patients With Presymptomatic Diabetes Type 1 (Stage 1)

Phase 2 Interventional PolTREG S.A. · NCT06688331

This study is testing if using special immune cells and a medication can help children at high risk for type 1 diabetes avoid getting the disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages6 Years to 16 Years
SexAll
SponsorPolTREG S.A. Industry-sponsored
Drugs / interventionsrituximab
Locations8 sites (Bialystok and 7 other locations)
Trial IDNCT06688331 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of regulatory T cell (Treg) preparations and the anti-CD20 antibody rituximab in children aged 6-16 who are at high risk for developing type 1 diabetes. Approximately 2500 high-risk subjects will be screened to randomize 150 participants with confirmed preclinical type 1 diabetes into different treatment groups, including Tregs, rituximab, and placebo. The study will monitor participants for the onset of type 1 diabetes over a maximum of five years following treatment. The trial is designed as a blinded, randomized, placebo-controlled study to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are children aged 6-16 with confirmed stage 1 type 1 diabetes and specific autoantibody profiles.

Not a fit: Patients who have already been diagnosed with stage 2 or 3 type 1 diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could delay or prevent the onset of type 1 diabetes in children at high risk.

How similar studies have performed: While the approach of using Treg cells and rituximab is innovative, similar studies have shown promise in related areas, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 6-16
2. 25 ≤ BMI ≤ 75 percentile (acc. to OLAF) with a lower weight threshold of 20 kg
3. Venous plasma glucose levels \< 100mg% at fasting (70 to 100 mg/dl) and normal glucose tolerance test (at 120 minutes glycaemia \<140 mg/dl) (acc. to PTD)
4. Insulin independence
5. C-peptide levels ≥ 1.0 ng/ml (central laboratory limit of normal) in fasting and post-stimulation tests increase ≥ 100%
6. Participant has not yet been diagnosed with stage 2 or 3 type 1 diabetes mellitus (no history of dysglycemia, no history of clinical symptoms of type 1 diabetes mellitus)
7. HbA1c level (%) \<5,7% (acc. to ADA)
8. Positive autoantibody titres (ICA, IAA, GAD, IA-2/ICA512, ZnT8) - low titers of two or more antibodies (2-4 times the normal\*); if high titer of one of the antibodies (≥ 4 times the norm, not applicable to ICA) re-screening allowed (the participant can be included in the trial only after confirming two or more antibodies)
9. Ability to give informed consent by the child's legal representatives (and the child himself or herself if he or she is over the age of 13 at the time of the trial \[according to local law\])
10. Ability of the child's legal representatives to manage diabetes, defined as blood glucose levels control at least three times a day and the ability to dose insulin correctly.
11. Venous access to guarantee blood donation

    Exclusion Criteria:
12. Refusal to participate in the trial or lack of a signed informed consent form
13. Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus
14. Age under 6 or above 16
15. IgA deficiency or history of other diagnosed immunodeficiency (max. 7 infections/year allowed, and the prognosis should indicate that the patient will remain in the study throughout its duration)
16. C-peptide levels \< 1.0 ng/ml fasting and in post-stimulation tests increase \< 100%
17. Glucose levels in venous blood ≥ 100mg% fasting
18. Glucose levels in venous blood after 1 and 2 hours in OGTT ≥ 200mg%
19. Glycated hemoglobin level (HbA1c) in venous blood ≥ 5,7%
20. BMI \< 25 or \> 75th percentile for a given age or weight of less than 20 kg
21. History of hypersensitivity to anti-CD20 or other components of the preparation
22. History of hypersensitivity to penicillin and/or streptomycin
23. Past or active infection with HBV, HCV, HIV, HTLV I/II, mycobacterium tuberculosis, syphilis. Laboratory evidence of infection without the need for clinical signs and symptoms is sufficient for diagnosis.
24. Active infection with the EBV or CMV virus (positive IgM)
25. Any fungal, parasitic, viral, or bacterial infection
26. History of past or active cancer
27. Anemia, lymphopenia, neutropenia, or thrombocytopenia defined as a blood cell count below the lower limit of normal for age found within the last 6 weeks prior to trial inclusion
28. Elevated thrombotic activity/history of thrombosis episode
29. Any disease prior to inclusion in the trial currently requiring medication for more than 3 months in history
30. Diagnosed autoimmune disease other than type 1 diabetes mellitus, including a history of Hashimoto's disease and coeliac disease
31. Taking anti-diabetic medication (including insulin) in the last 4 weeks prior to trial inclusion
32. History of retinopathy
33. History of hypertension
34. Current or history of albuminuria
35. For women in childbearing potential/menstruating women: pregnancy (from medical interview) or unwillingness to exercise sexual restraint or use effective forms of contraception for the duration of the trial and up to 4 months after completion, if applicable.

    The following contraceptive methods are acceptable: bilateral fallopian tube closure, sterilization in men, appropriate use of hormonal contraception that inhibits ovulation, hormone-releasing IUDs, and copper IUDs, male or female condoms with spermicide; and cap, uterine disc, or sponge with spermicide.
36. Breastfeeding
37. For males over 15 years of age: expressed intention to have offspring or donate sperm during the trial or within 4 months after the end of the trial, if applicable
38. Excessive anxiety of the participant or his/her legal representatives regarding the procedures used in the trial
39. Any medical problem that, in the opinion of the investigator, may adversely affect the participant's health if included in the trial
40. Legal representatives and/or children over the age of 15 with an identified alcohol and/or psychoactive substance addiction
41. History of disease of unknown etiology
42. History of Creutzfeldt-Jacob disease
43. History of progressive dementia or degenerative neurological disease, including of unknown origin
44. History of taking hormones derived from the human pituitary gland (e.g., growth hormone)
45. Treatment with immunosuppressants
46. History of corneal, scleral, and dural transplant or undocumented neurosurgery
47. History of occurrence of risk factors related to the participant's travel, where there is a possibility of exposure to regional infectious diseases
48. Physical signs that indicate the risk of an infectious disease
49. History of xenogeneic transplant

Where this trial is running

Bialystok and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Presymptomatic Diabetes Type 1Diabetes Mellitus, Type IDiabetes Mellitus, Type 1PreTregTregsPrediabetespresymptomatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.