Could engineered immune cells free diabetics from insulin shots?
NCT ID NCT07528105
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a single infusion of genetically modified immune cells (CAR-T cells) designed to target and calm the immune attack that causes type 1 diabetes. Nine adults with early-stage type 1 diabetes will receive the cells and be monitored for safety, insulin needs, and beta-cell function. The goal is to see if this approach can preserve the body's ability to produce insulin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic CD7-targeted CAR-T cells (RD13-02)
- What this could lead to
- If it works, this could point toward a way to preserve the body's own insulin production and reduce dependence on insulin injections for people with early type 1 diabetes.
- What could go wrong
- This is a very early, small trial (9 people) testing safety first. The treatment may not work, could cause serious side effects, and any benefit may be temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years and ≤40 years. * Participants with stage 2 or stage 3 type 1 diabetes mellitus, according to the staging criteria for type 1 diabetes defined in the ADA 2024 Standards of Care in Diabetes. * Positive for at least one islet autoantibody at screening, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), insulin autoantibody (IAA) (applicable only to participants who have received insulin therapy for no more than 2 weeks), zinc transporter 8 autoantibody (ZnT8A), or islet cell autoantibody (ICA). Participants positive for two or more autoantibodies will be prioritized for enrollment. * Peak C-peptide \>0.2 nmol/L during a mixed-meal tolerance test (MMTT), or fasting C-peptide \>0.1 nmol/L. * The participant or his/her legally authorized representative voluntarily agrees to participate in the study and is able to sign the informed consent form. Exclusion Criteria: * Any type of diabetes other than type 1 diabetes, such as gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary forms of diabetes (for example, diabetes caused by Cushing syndrome, thyroid dysfunction, or acromegaly). * Hematologic abnormalities at screening, including hemoglobin \<100 g/L, white blood cell count \<3 × 10\^9/L, neutrophil count \<1.5 × 10\^9/L, or platelet count \<75 × 10\^9/L. * Liver injury at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN. * Severe heart disease, such as angina pectoris, myocardial infarction, heart failure, or clinically significant arrhythmia. * kidney disease, including severe diabetic kidney disease, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², current or expected receipt of renal replacement therapy. * Ongoing use of medications that, in the investigator's judgment, may cause significant and sustained changes in the course of type 1 diabetes or immune status. * Uncontrolled diabetic ketoacidosis. * Uncontrolled infection at screening, or any of the following at screening: positive hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBeAb) with peripheral blood HBV DNA above the upper limit of normal; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; positive Epstein-Barr virus-encoded RNA (EBER), or EBV viral load above the upper limit of normal. * Active autoimmune disease other than type 1 diabetes that requires systemic immunotherapy or is associated with organ dysfunction. * Pregnant or breastfeeding women; participants planning to conceive within 1 year; or participants of childbearing potential who are unwilling to use effective contraception during the study. * History of malignancy, except for cases considered by the investigator to be cured and at no risk of recurrence. * Participation in another clinical study within 3 months before enrollment. * Receipt of a live attenuated vaccine within 4 weeks before enrollment, or plan to receive a live attenuated vaccine during the study period. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, 201508, China
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