Clin2
NCT06688331Possibly a fitRecruiting

Treating early stage 1 type 1 diabetes in children with cell therapy and antibody

Presymptomatic Diabetes Type 1 (Stage 1)Diabetes Mellitus, Type IDiabetes Mellitus, Type 1

Part of Hormones & metabolism, Immune system & allergy clinical trials.

This trial tests a new combination treatment for children who have been diagnosed with stage 1 type 1 diabetes, meaning they have some markers but do not yet need insulin. The treatment uses special immune cells (Treg cells) and an antibody (anti-CD20) to try to preserve the body's ability to make insulin.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
150 people
Ages
3 years to 18 years
Study type
Interventional

Who can take part

  • Child must be between 3 and 18 years old and weigh at least 44 pounds (20 kg).
  • Must have positive antibodies (at least two different types) that show the immune system is attacking the pancreas.
  • Must still produce a normal amount of insulin (fasting C-peptide at least 1.0 ng/mL) and have normal blood sugar levels.
  • Cannot have used any diabetes medications, including insulin, in the past 4 weeks.
  • Child must not have any other autoimmune diseases, like Hashimoto's or celiac disease.
  • Must be able to come to appointments and receive intravenous treatments.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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