BridgeMD
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)
EU CTIS ID: 2023-505226-33-00
What this study is testing
To assess the safety and efficacy of the treatment used in the separate groups of pediatric participants with DM1 stage 1 treated with two-dose combination regimen of Tregs and rituximab over placebo, rituximab alone, and Tregs alone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 3-18
- 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
- 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
You likely can't join if
- Refusal to participate in the trial or lack of a signed informed consent form
- 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
See the full eligibility criteria
Who can join
- Age 3-18
- 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
- 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 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)
- 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])
What rules you out
- Refusal to participate in the trial or lack of a signed informed consent form
- 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 reported in the medical history prior to inclusion in the trial that has required continuous treatment for more than 3 months with medication directly affecting the immune system (e.g., immunosuppressive, immunomodulatory or immunostimulatory therapy). This does not include chronic treatment with drugs without a primary immunological mechanism of action.
- Diagnosed autoimmune disease other than type 1 diabetes mellitus, including a history of Hashimoto's disease and coeliac disease
- Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus
- 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
- 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
- Age under 3 or above 18
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.