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

A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-Targeted CAR-T Cell Injection for the Treatment of Type 1 Diabetes Mellitus

This trial will test an off-the-shelf anti-CD7 CAR-T cell therapy in adults 18–40 with stage 2 or 3 type 1 diabetes to see if it can safely reduce the immune attack on insulin-producing beta cells.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: immunotherapy, CAR-T
• Locations: 1 site (Shanghai)
• Trial ID: NCT07528105 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–40 with stage 2 or stage 3 type 1 diabetes who are positive for at least one islet autoantibody and have preserved C-peptide (peak >0.2 nmol/L or fasting >0.1 nmol/L) and can consent to the protocol and follow-up.

Not a fit: Patients with other forms of diabetes, absent or very low C-peptide, significant uncontrolled medical conditions, or those outside the 18–40 age window are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the therapy could preserve residual beta-cell function and reduce future insulin needs by targeting the autoreactive immune cells that drive the disease.

How similar studies have performed: This exact CD7-targeted allogeneic CAR-T approach for type 1 diabetes is largely novel; while other immunotherapies and some cellular approaches have shown variable results in autoimmune disease, human data for CD7 CAR-T in T1D are limited.

Eligibility criteria

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 this trial is running

Shanghai

• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jingjing JIANG, MD, PhD

Conditions T1DM - Type 1 Diabetes Mellitus; T1DM; Allogeneic CD7-Targeted CAR-T Cell