Allogeneic anti-CD7 CAR-T therapy for type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase 1 trial will administer allogeneic CD7-targeted CAR-T cells to adults aged 18–40 with stage 2 or 3 type 1 diabetes who are positive for at least one islet autoantibody and have measurable C-peptide. The primary aim is to establish safety and tolerability with close monitoring for immune-related and infusion-related toxicities, likely using a dose-escalation design. Exploratory outcomes will include mixed-meal tolerance test C-peptide, changes in autoantibody status, and insulin requirements over follow-up. Treatment and monitoring will occur at Zhongshan Hospital with scheduled clinic visits and laboratory assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jingjing JIANG, MD, PhD
• Email: jiang.jingjing@zs-hospital.sh.cn
• Phone: 86-021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.