Presymptomatic Diabetes Type 1 (Stage 1)Phase 2PreTregNCT06688331
Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody
A Phase 2 study testing ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs) and Anti-CD20 (rituximab) in people with Presymptomatic Diabetes Type 1 (Stage 1) and Diabetes Mellitus, Type I, run by PolTREG S.A. at 9 sites in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Presymptomatic Diabetes Type 1 (Stage 1), Diabetes Mellitus, Type I, Diabetes Mellitus, Type 1
- What is being tested?
- ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs) and Anti-CD20 (rituximab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 9 sitesPoland
- Study dates
- 12 Mar 2025to Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 3-18
- 5 ≤ BMI ≤ 95 percentile (acc. to OLAF, or WWF in the case of children under six years old) with a lower weight threshold of 20 kg
- 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)
- Insulin independence
- C-peptide levels ≥ 1.0 ng/ml (central laboratory limit of normal) in fasting and post-stimulation tests increase ≥ 100%
- 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)
Show all 12Show fewer
- HbA1c level (%) <5,7% (acc. to ADA)
- Positive autoantibody titres (ICA, IAA, GAD, IA-2/ICA512, ZnT8) - low titers of two or more antibodies (2 times the normal* or higher); 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)
- 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])
- 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.
- Venous access to guarantee blood donation
- Standard defined depending on the method used
Who cannot join
- Refusal to participate in the trial or lack of a signed informed consent form
- Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus
- Age under 3 or above 18
- 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)
- C-peptide levels < 1.0 ng/ml fasting and in post-stimulation tests increase < 100%
- Glucose levels in venous blood ≥ 100mg% fasting
Show all 39Show fewer
- Glucose levels in venous blood after 1 and 2 hours in OGTT ≥ 200mg%
- Glycated hemoglobin level (HbA1c) in venous blood ≥ 5,7%
- BMI < 5th percentile or > 95th percentile for age, or body weight < 20 kg
- History of hypersensitivity to anti-CD20 or other components of the preparation
- History of hypersensitivity to penicillin and/or streptomycin
- 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.
- Active infection with the EBV or CMV virus (positive IgM)
- Any fungal, parasitic, viral, or bacterial infection
- History of past or active cancer
- 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
- Elevated thrombotic activity/history of thrombosis episode
- Any disease prior to inclusion in the trial currently requiring medication for more than 3 months in history
- Diagnosed autoimmune disease other than type 1 diabetes mellitus, including a history of Hashimoto's disease and coeliac disease
- Taking anti-diabetic medication (including insulin) in the last 4 weeks prior to trial inclusion
- History of retinopathy
- History of hypertension
- Current or history of albuminuria
- 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.
- Breastfeeding
- 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
- Excessive anxiety of the participant or his/her legal representatives regarding the procedures used in the trial
- Any medical problem that, in the opinion of the investigator, may adversely affect the participant's health if included in the trial
- Legal representatives and/or children over the age of 15 with an identified alcohol and/or psychoactive substance addiction
- History of disease of unknown etiology
- History of Creutzfeldt-Jacob disease
- History of progressive dementia or degenerative neurological disease, including of unknown origin
- History of taking hormones derived from the human pituitary gland (e.g., growth hormone)
- Treatment with immunosuppressants
- History of corneal, scleral, and dural transplant or undocumented neurosurgery
- History of occurrence of risk factors related to the participant's travel, where there is a possibility of exposure to regional infectious diseases
- Physical signs that indicate the risk of an infectious disease
- History of xenogeneic transplant
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Poland9 sites, 9 recruiting
- Recruiting
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Bialystok, 15-269
Artur Bossowski, prof
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-211
Matylda Hennig, Dr
- Not yet recruiting
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Katowice, 40-752
Przemyslawa Jarosz-Chobot, prof
- Recruiting
Uniwersytet Medyczny W Lodzi
Lodz, 90-419
Agnieszka Szadkowska, prof
- Recruiting
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, 20-093
Iwona Ben-Skowronek, prof
- Recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
Agata Chobot, prof
- Recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
Rzeszów, 35-326
Artur Mazur, prof
- Recruiting
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 71-252
Kornelia Jankowska, +48510926939, kornelia.jankowska@pum.edu.pl
Elżbieta Petriczko, Prof
- Recruiting
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, 50-556
Agnieszka Zubkiewicz-Kucharska, dr
About this study
Official title: 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)
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).
Read more
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 3-18 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.
Read the detailed description
Participants: screening of approximately 2500 high-risk subjects will be conducted until no less than 150 participants with confirmed stage 1 (preclinical) type 1 diabetes mellitus are randomized; randomization 2:1:1:2; 50 participants treated with Tregs and anti-CD20 antibody; 25 participants treated with Tregs; 25 participants treated with anti-CD20 antibody; control: 50 participants receiving placebo and sham Tregs.
Inclusion of participants: up to 36 months. Trial intervention: Total duration of the trial intervention for each participant will be approximately 3 Months. After completion of the trial intervention, participants will be monitored at the sites for the onset of type 1 diabetes mellitus for a maximum of five years counting from the first dose of Tregs.
Follow-up time: post-treatment observation of all participants to 57 months (day "0" is the day of administration of the first dose of Treg/sham preparation).
Trial time: 96 months. Trial type: Prospective randomized (phase 2), placebo-controlled, parallel group, blinded trial.
Blinding: The following roles indicated below will not be made aware of the treatment group assignment during the trial:
- participant
- legal representatives
- site staff excluding pharmacists (applies to anti-CD20only)
- Conditions
- Presymptomatic Diabetes Type 1 (Stage 1), Diabetes Mellitus, Type I, Diabetes Mellitus, Type 1
- Being tested
- ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs), Anti-CD20 (rituximab), Placebo, Treg sham
- Keywords
- PreTreg, Tregs, Prediabetes, presymptomatic
- Medical subject headings
- Diabetes Mellitus, Type 1, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs)Biological
Also called Tregs, regulatory T cells
regulatory T cells with the phenotype CD3(+)CD4(+)CD25(high)CD127(-)doublet(-)lin(-)
Anti-CD20 (rituximab)Biological
Also called Mabthera
rituximab
PlaceboOther
intrevenous 0,9% NaCl
Treg shamOther
intrevenous 0,9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| TregsCD20 | Experimental | Infusion of Treg preparation at "day 0" + 4 doses of antiCD20 antibody; second infusion of Treg preparation at time "+90 (+30) days" Interventions: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs) + Anti-CD20 (rituximab) Receives: Biological: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs); Biological: Anti-CD20 (rituximab) |
| Tregs only | Experimental | Infusion of Treg preparation at "day 0" + 4 doses of placebo; second infusion of Treg preparation at time "+90 (+30) days" Receives: Biological: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs); Other: Placebo |
| CD20 only | Experimental | Infusion of Treg sham at "day 0" + 4 doses of antiCD20 antibody; second infusion of Treg sham at time "+90 (+30) days" Receives: Biological: Anti-CD20 (rituximab); Other: Treg sham |
| Control group | Placebo comparator | Infusion of Treg sham at "day 0" + 4 doses of placebo; second infusion of Treg sham at time "+90 (+30) days" Receives: Other: Placebo; Other: Treg sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia or in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at the end of the trial
To assess the safety and efficacy of the treatment used in the separate groups of participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/Tregs sham)
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms
To assess the safety and efficacy of the treatment used in the separate groups of participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/Tregs sham)
Measured: From enrollment to the end of participation in the trial at month 60 (day "0" is the day of administration of the first dose of Treg preparation)
Secondary outcomes (7)
Pace of diabetes development. Total number of days from the date of diagnosis of stage 2 to the date of onset of full-blown type 1 diabetes mellitus (stage 3 of type 1 diabetes mellitus) in each group (normalized to the number of person/days in each grou
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Number of days from day 0 to the day of first dysglycemia (stage 2 of type 1 diabetes mellitus) in each group
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Cumulative diabetes incidence [only the progression to stage 3 considered as diabetes incidence]
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
C-peptide levels [fasting/post MMTT stimulation (AUC)] 1 year, 2 years after the first dose of Tregs and then annually until the end of the trial comparing to control arms
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Daily average dose of insulin per kg body weight (DDI) 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial in each arm of the trial
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Number of participants per arm in remission 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial, [remission defined as daily insulin dose is less than 0.5U/kg/day with an HbA1c level less than 6.5%]
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Assessment of the incidence and severity of adverse events associated with the administration of Treg preparation or anti-CD20 antibody, primarily the effects of immunosuppression: incidence of infections of any etiology and de novo tumors detected
Additional measures to assess the safety and efficacy of the treatment used in the separate groups of pediatric participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/ Tregs sham) in preserving β-cell function
Measured: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start12 Mar 2025
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presymptomatic Diabetes Type 1 (Stage 1)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial type: Prospective randomized, placebo-controlled, parallel group, blinded trial. Control method: placebo, active comparator, sham procedure.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PolTREG S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Invicta Sp. z o.o., Medical Research Agency, Poland, Clinmark Clinical Research
- Responsible party
- Sponsor
- Investigators
- Piotr Trzonkowski, Prof, Study director, PolTREG S.A.Artur Bossowski, Prof, Principal investigator, Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W BialymstokuWojciech Mlynarski, Prof, Study chair, Uniwersytet Medyczny W Lodzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688331
- Sponsor's protocol ID
- PTG007-DM1-preTREG-001
- Other IDs
- 2023-505226-33-00, 2023
- Acronym
- PreTreg
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06688331
- Acronym / sponsor ID
- PreTreg / PTG007-DM1-preTREG-001
- Conditions
- Presymptomatic Diabetes Type 1 (Stage 1), Diabetes Mellitus, Type I, Diabetes Mellitus, Type 1
- Keywords
- PreTreg, Tregs, Prediabetes, presymptomatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- PolTREG S.A.Industry (pharma, biotech, devices)
- Collaborators
- Invicta Sp. z o.o., Medical Research Agency, Poland, Clinmark Clinical Research
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 3-18 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.
Detailed description
Participants: screening of approximately 2500 high-risk subjects will be conducted until no less than 150 participants with confirmed stage 1 (preclinical) type 1 diabetes mellitus are randomized; randomization 2:1:1:2; 50 participants treated with Tregs and anti-CD20 antibody; 25 participants treated with Tregs; 25 participants treated with anti-CD20 antibody; control: 50 participants receiving placebo and sham Tregs.
Inclusion of participants: up to 36 months. Trial intervention: Total duration of the trial intervention for each participant will be approximately 3 Months. After completion of the trial intervention, participants will be monitored at the sites for the onset of type 1 diabetes mellitus for a maximum of five years counting from the first dose of Tregs.
Follow-up time: post-treatment observation of all participants to 57 months (day "0" is the day of administration of the first dose of Treg/sham preparation).
Trial time: 96 months. Trial type: Prospective randomized (phase 2), placebo-controlled, parallel group, blinded trial.
Blinding: The following roles indicated below will not be made aware of the treatment group assignment during the trial:
- participant
- legal representatives
- site staff excluding pharmacists (applies to anti-CD20only)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Trial type: Prospective randomized, placebo-controlled, parallel group, blinded trial. Control method: placebo, active comparator, sham procedure.
| Arm | Type | Receives |
|---|---|---|
| TregsCD20 | Experimental | Biological: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs), Biological: Anti-CD20 (rituximab)Infusion of Treg preparation at "day 0" + 4 doses of antiCD20 antibody; second infusion of Treg preparation at time "+90 (+30) days" Interventions: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs) + Anti-CD20 (rituximab) |
| Tregs only | Experimental | Biological: ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs), Other: PlaceboInfusion of Treg preparation at "day 0" + 4 doses of placebo; second infusion of Treg preparation at time "+90 (+30) days" |
| CD20 only | Experimental | Biological: Anti-CD20 (rituximab), Other: Treg shamInfusion of Treg sham at "day 0" + 4 doses of antiCD20 antibody; second infusion of Treg sham at time "+90 (+30) days" |
| Control group | Placebo comparator | Other: Placebo, Other: Treg shamInfusion of Treg sham at "day 0" + 4 doses of placebo; second infusion of Treg sham at time "+90 (+30) days" |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age 3-18
- 5 ≤ BMI ≤ 95 percentile (acc. to OLAF, or WWF in the case of children under six years old) with a lower weight threshold of 20 kg
- 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)
- Insulin independence
- C-peptide levels ≥ 1.0 ng/ml (central laboratory limit of normal) in fasting and post-stimulation tests increase ≥ 100%
Key exclusion criteria (39 listed)
- Refusal to participate in the trial or lack of a signed informed consent form
- Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus
- Age under 3 or above 18
- 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)
- C-peptide levels < 1.0 ng/ml fasting and in post-stimulation tests increase < 100%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs)Also: Tregs, regulatory T cellsregulatory T cells with the phenotype CD3(+)CD4(+)CD25(high)CD127(-)doublet(-)lin(-) | Biological | Tregs only, TregsCD20 |
| Anti-CD20 (rituximab)Also: Mabtherarituximab | Biological | CD20 only, TregsCD20 |
| Placebointrevenous 0,9% NaCl | Other | Control group, Tregs only |
| Treg shamintrevenous 0,9% NaCl | Other | CD20 only, Control group |
Primary outcome
% of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia or in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at the end of the trial
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
To assess the safety and efficacy of the treatment used in the separate groups of participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/Tregs sham)
Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms
Time frame: From enrollment to the end of participation in the trial at month 60 (day "0" is the day of administration of the first dose of Treg preparation)
To assess the safety and efficacy of the treatment used in the separate groups of participants treated with combined treatment with Treg preparation and rituximab antibody or Treg preparation or rituximab antibody or the control (placebo/Tregs sham)
7 secondary outcomes
Pace of diabetes development. Total number of days from the date of diagnosis of stage 2 to the date of onset of full-blown type 1 diabetes mellitus (stage 3 of type 1 diabetes mellitus) in each group (normalized to the number of person/days in each grou
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Number of days from day 0 to the day of first dysglycemia (stage 2 of type 1 diabetes mellitus) in each group
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Cumulative diabetes incidence [only the progression to stage 3 considered as diabetes incidence]
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
C-peptide levels [fasting/post MMTT stimulation (AUC)] 1 year, 2 years after the first dose of Tregs and then annually until the end of the trial comparing to control arms
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Daily average dose of insulin per kg body weight (DDI) 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial in each arm of the trial
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Number of participants per arm in remission 1 year, 2 years after the first dose of Tregs, and annually thereafter until the end of the trial, [remission defined as daily insulin dose is less than 0.5U/kg/day with an HbA1c level less than 6.5%]
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Assessment of the incidence and severity of adverse events associated with the administration of Treg preparation or anti-CD20 antibody, primarily the effects of immunosuppression: incidence of infections of any etiology and de novo tumors detected
Time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- CTISLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Trzonkowski, Prof study director
PolTREG S.A.
Artur Bossowski, Prof principal investigator
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Wojciech Mlynarski, Prof study chair
Uniwersytet Medyczny W Lodzi
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs) and Anti-CD20 (rituximab) in people with Presymptomatic Diabetes Type 1 (Stage 1) and Diabetes Mellitus, Type I, run by PolTREG S.A. at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Druch, Clinical Trial Director (+48731471845, m.druch@poltreg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia or in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at the end of the trial (time frame: From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.